Ensuring Health Care Providers Have Comprehensive Communication Tools for Future Microbicide Introduction in Kenya: A Formative Research Study

Abstract

As the field of HIV prevention advances and new antiretroviral (ARV)-based prevention products are developed, health care providers will play a critical role in promoting or limiting new product use. To provide evidence-based communication supporting potential product roll-out, we developed and assessed a suite of vaginal microbicide communication materials tailored to various Kenyan audiences. However, our materials could potentially be adapted for use with other ARV-based prevention products and settings. For health care providers, we developed three sets of materials: informational brochures, wall charts, and a counseling flip chart. Trained research assistants conducted 24 in-depth interviews with providers from a range of health facilities in Nairobi and Nakuru, Kenya. Interviews assessed providers’ current HIV counseling practices for women in different types of sexual relationships, attitudes toward vaginal microbicide gel, and thoughts on the content and usefulness of the microbicide communication materials; priority was given to the counseling flip chart. Interviews also included hypothetical counseling scenarios to assess providers’ potential to appropriately use materials and adapt their counseling techniques. Microbicide communication materials were well received and effective in educating providers about microbicides and in helping them provide appropriate counseling for hypothetical scenarios involving women in different sexual contexts.

Keywords

microbicides HIV women Kenya

Globally, women remain disproportionately affected by HIV (Joint United Nations Programme on HIV/AIDS, 2013). A number of biological, structural, sociocultural, and behavioral factors, including an inability to use condoms with some partners, contributes to this disparity (Joint United Nations Programme on HIV/AIDS, 2013; Mastro, Sista, & Abdool-Karim, 2014). However, the promising development of new antiretroviral (ARV)-based HIV prevention products, including vaginal gels and rings, and oral and injectable pre-exposure prophylaxis, may result in realistic new HIV prevention options for women.

Health care providers are likely to be the gateway to accessing any ARV-based HIV prevention product, and a woman’s decision to use a new product may be directly linked to her experience at the health facility. For safety reasons, routine HIV testing will be required to ensure that prevention drugs are only used by those who test negative. Moreover, as demonstrated by previous clinical trials, high levels of adherence will be critical to ensure product effectiveness (Corneli et al., 2014; Marrazzo et al., 2013). Health care providers will, therefore, play a key role in both disseminating information and supporting new product uptake and adherence. To do this, they will require comprehensive counseling tools and tailored patient communication materials. They will also need to be well prepared to provide accurate, thorough, and nonbiased product introduction and adherence coun-seling to any woman interested in ARV-based HIV prevention. Strategically developing and assessing draft communication materials, ahead of new product licensure and marketing, can potentially reduce stigma and lead to a more seamless product introduction.

Background

As part of the Communicating about Microbicides with Women in Mind project, we developed and assessed a suite of microbicide communication materials tailored to various Kenyan audiences, including health care providers (Ryan et al., 2015; Sidibe et al., 2014; Tolley et al., 2014). For potential product end-users, we assessed whether interest in microbicide use was influenced by how the product was framed—strictly as an HIV prevention product or as a product that could increase intimacy or sexual pleasure while reducing risk. Framing has been described elsewhere in detail (Ryan et al., 2015; Tolley et al., 2014). For health care providers, however, the materials offered in-depth information about both HIV and non-HIV related benefits of microbicides. The project was part of a larger USAID-funded effort to support microbicide introduction if/when a vaginal microbicide gel is proven effective.

At the time of this study, vaginal microbicide gel was formulated as a coitally dependent gel that women could use for partial protection against HIV with or without their partner’s knowledge (Abdool Karim et al., 2010; Mastro et al., 2014). The CAPRISA 004 clinical trial in South Africa had provided proof of concept in 2010 that a vaginal gel containing an ARV drug could reduce risk of HIV, and researchers were hoping to replicate the results in the FACTS 001 trial. The use regimen was known as BAT-24. It required that women insert microbicide gel vaginally up to 12 hours Before sex, and immediately following or up to 12 hours After the first sex act. It also required that women insert no more than Two doses in 24 hours, regardless of the number of sex acts they participated in. However, the final results of the FACTS 001 trial have since stalled development of this particular regimen (Rees et al., 2016), and other more user-friendly ARV-based prevention options are currently being promoted (AVAC, 2016). Despite this, we believe that the novel Communicating about Microbicides with Women in Mind study offers useful lessons for new product introduction. The information contained in our communication materials, and the materials themselves, could potentially be adapted for use both in other settings and with other new ARV-based HIV prevention products.

Details of the material development process have been described elsewhere (Ryan et al., 2015). In summary, we developed three sets of materials for one-on-one use between health care providers and their clients.

English and Swahili versions of a trifold informational brochure provided a brief introduction to the safety, effectiveness, and use instructions of microbicide gel. Once unfolded, the inside face of the brochure contained a step-by-step depiction of a partially-dressed woman inserting the gel. The brochure also contained information about the gel and encouraged women to seek more information about the gel from their health care providers.

Two separate wall charts were developed to outline step-by-step counseling processes for introducing microbicides to women at risk of HIV. One wall chart was intended for use in HIV testing and counseling (HTC) settings, while the second was intended for use in non-HTC settings, such as family planning, primary care, sexually transmitted infection (STI), or youth-friendly facilities. The primary difference between the two was the timing in which microbicide information and HIV testing were introduced. Because clients visiting HTC facilities are specifically interested in HIV testing, that algorithm began with an HIV risk assessment followed by testing and, for HIV negative women, information on various prevention options including microbicides. For those visiting non-HTC facilities, that algorithm also began with an HIV risk assessment but was followed by an introduction to prevention options, including microbicides. Testing at non-HTC facilities would therefore only be offered to those who expressed interest in microbicide use.

A desktop flip chart was designed to provide detailed counseling guidance to providers for microbicide introduction with clients. Each provider-facing card included questions, discussion points, and notes for a specific topic, while each client-facing card depicted a relevant illustration. In particular, the flip chart included information on the following topics:

HIV risk assessment

Available HIV prevention options

Overview of microbicides, their safety and effectiveness

Instructions for correct and consistent microbicide use

How to discuss microbicides with a partner

How to negotiate the use of microbicides together with condoms

How to overcome barriers to correct and consistent use

Follow-up counseling

To ensure accuracy, colleagues who conducted the CAPRISA 004 trial reviewed initial drafts of the materials. Similarly, our local project advisory committee and local health care organizations, such as LVCT and Family Health Options of Kenya, offered culturally relevant input, including information on whether and how the materials might eventually be adapted and integrated into existing health facility protocols in Kenya.

The conceptual framework, shown in Figure 1, provides a structure for our assessment of provider-oriented materials. In particular, the framework assumes that providers’ ability to deliver appropriate, tailored microbicide counseling to all women at risk of HIV will require supportive materials that promote correct knowledge of microbicides, including information on product safety, effectiveness, and accurate use instructions for all women, regardless of sexual risk contexts; lead to favorable attitudes toward microbicides as an HIV prevention method; and can be easily integrated into existing clinic routines.

Figure 1.

Conceptual framework.

The materials developed by the Communicating about Microbicides with Women in Mind study were designed to meet these needs, and to be adaptable for use in the introduction of other new ARV-based HIV prevention products. However, we recognize that future effectiveness of the materials will also depend on factors beyond the scope of this project, including the future licensure of microbicides for HIV prevention, the need for provider training on use of the materials and further assessment of how best to integrate counseling algorithms into existing clinic protocols.

Method

For this formative study, all materials underwent two rounds of pretesting (Ryan et al., 2015) and formal research evaluation (Tolley et al., 2014). The Kenya Medical Research Institute (KEMRI) granted ethical nonresearch approval for the stakeholder engagement and material development activities, while ethical research approval was granted by both KEMRI and FHI 360’s Protection of Human Subjects Committee for material assessment activities.

We recruited 24 health care providers (nurses and physicians) from a range of public, faith-based, and nongovernmental organization facilities in urban Nairobi and peri-urban Nakuru, Kenya (see Table 1). Each provider received a copy of the materials several days prior to participating in a semistructured interviews to assess the feasibility, acceptability, and potential usefulness of the materials for counselling women about a vaginal gel for HIV prevention. Trained research assistants obtained oral voluntary informed consent from providers before initiating the interviews. Interviews were conducted in English, audio-recorded, and transcribed; transcripts were uploaded into NVivo 10.0 for coding and iterative content analysis. Two separate analysts coded the data using a team-approved codebook, and intercoder reliability was assessed at scheduled intervals. Any coding discrepancies were discussed and revised accordingly. Memos were developed to further describe major themes, such as provider understanding of the current insertion regimen (BAT 24), microbicide effectiveness and safety, as well as opinions of the materials and implementation concerns.

Table 1.

In-Depth Interviews by Facility and City.^a

Facility type	City
Facility type	Nairobi	Nakuru
Non-HTC facilities	FHOK Eastleigh, YFS	FHOK Nakuru, YFS
	FHOK Ribeiro, FP	FHOK Nakuru, FP
	LVCT, FP	FHOK Nakuru, FP
	Coptic, FP	Mother Kevin, FP
	NCCK Huruma, FP	Mother Kevin, FP
	Langata, FP	Langa Langa, FP
	Makadara, OPD	Forest, OPD
HTC facilities	SWOP, HTC/VCT	FHOK Nakuru, HTC/VCT
	Coptic, HTC/VCT	Mother Kevin, HTC/VCT
	NCCK Huruma, HTC/VCT	Mother Kevin, HTC/VCT
	STC Casino, HTC/VCT	PGH, HTC/VCT
	STC Casino, STI	PGH, STI

Note. FP = family planning clinic; HTC/VCT = HIV treatment and care/voluntary counseling and testing site; OPD = outpatient department; PGH = provincial general hospital; STI = sexually transmitted infection clinics (generally working with female sex workers); YFS = youth-friendly services.

No other demographic information was collected about the providers interviewed.

The purpose of the interviews was to assess providers’ current HIV counseling practices for women in different types of sexual relationships; attitudes toward vaginal microbicide gel; thoughts on the content and usefulness of the microbicide communication materials; and potential to appropriately use materials during hypothetical microbicide counseling with women.

Interviews consisted of a general discussion of each material, including providers’ overall opinions of the materials and details about how the materials might be used within the facility context. Priority, however, was given to the flip chart. Each counseling card in the flip chart was assessed for clarity of information, acceptability and relevance of messages, and provider’s potential use of the information within their clinic context. Hypothetical counseling scenarios for women in various HIV risk contexts were employed after the flip chart discussions. These were used to assess providers’ abilities to adapt HIV counseling techniques. One of seven scenarios was assigned to each provider based on the type of clients they were most likely to see. A description of the scenarios is provided in Table 2.

Table 2.

Hypothetical Counseling Scenarios.

Scenario	Description
Joyce, a 17-year-old boarding school student	She does not have a boyfriend but sometimes has sex with boys she meets, like when there are events with other schools. She goes to go to college and wants to get married one day.
Makena, an 18-year-old woman who left Form 1^a	She earns her living selling chips and is a single mother of a 1-year-old boy. She has a serious boyfriend, but also sometimes has sex with her son’s father in exchange for financial support.
Mercy, a 24-year-old woman who finished Form 4^a	She works in a clothing store and loves fashion. She does not have a boyfriend her age, but she sees an older married man who buys her nice things. She wants to own a store one day.
Rosemary and Samuel, a married couple in their 30s	They have been happily married for 6 years. Samuel is a pilot who frequently works away from home. Rosemary knows he loves her, but she wonders if he sometimes has other sex partners. She would like to conceive.
Alice and Gilbert, a casual couple in their early 20s	They have been seeing each other for a few weeks and like having fun together. Gilbert is a matatu (bus) driver and Alice is a waitress in a nyama choma (BBQ) restaurant.
Leila, a 28-year-old brothel-based sex worker	She is single with two children and works in a salon during the day.
Lucy, a 20-year-old street-based sex worker	She is single with a 1-year-old son. She does not have a day job and finds it hard to make ends meet.

In the Kenyan educational system, Form 1 refers to 14 to 15 year olds, while Form 4 refers to 17 to 18 year olds.

Results

Correct Knowledge of Microbicides

As indicated previously, equipping providers with correct knowledge about new ARV-based HIV preven-tion products, including information on proper use instructions, and product effectiveness is critical. We strategically developed the microbicide communication materials with this in mind, and most providers felt the materials sufficiently covered these necessary topics.

Because the BAT-24 microbicide use regimen was fairly complicated, there were several cards in the flip chart dedicated to describing it. After reviewing the cards with providers, we assessed providers’ understanding of the current use regimen based on their knowledge of necessary gel insertion before sex, after sex, and no more than two doses within 24 hours. Less than half of all providers were able to correctly explain the BAT 24 regimen in their own words, without assistance. Yet one provider from a family planning facility accurately summarized:

The gel should be inserted not more than 12 hours before sex but at least 15 minutes before the actual interval . . . once you have had the first sexual intercourse . . . it should also be immediately inserted after the sexual intercourse or not more than 12 hours after sex . . . so within 24 you should have inserted the two gels. (Nairobi non-HTC provider)

A few additional providers from a range of facilities, however, were able to correctly explain the regimen after the interviewer provided minor clarification. Insertion before sex seemed to be the easiest component for providers to describe, with most providers recognizing that the gel needed to be inserted at least 15 minutes before sex. In contrast, the appropriate timing for insertion after sex seemed to be the most difficult component of BAT 24 for providers to grasp. For example, one provider thought the regimen was to “insert again after the act . . . insert after 24 hours” (Nairobi non-HTC provider).

To communicate the partial effectiveness of microbicides and to discourage potential condom migration, defined as the movement from more effective condom use to less effective gel use only, the flip chart also contained a card depicting an HIV risk hierarchy: with those who use no protection at greatest risk, gel only at reduced risk, condoms only at low risk, and condoms and gel together at very low risk. More than half of providers reported that the information on the chart was very clear and that the hierarchy was well explained. Moreover, all but one provider demonstrated an understanding that microbicides alone are only partially effective against HIV acquisition, and that in order to increase protection, they can be combined with condom use.

I think the flip chart has information that using the condom plus the gel is highly effective in preventing HIV transmission: like in case the condom bursts, the cream acts as a backup. So, it gives enough information. (Nairobi non-HTC provider)

Attitudes Toward Microbicides and Related Introduction Concerns

Nearly all providers had a positive overall opinion of microbicides, indicating that incorporating microbicides into the available mix of HIV prevention options would benefit women in general. As depicted in the following quotes, these providers also specifically liked the idea that vaginal microbicide gel could provide women with a prevention option they could initiate for themselves:

I think the introduction of microbicides will be very effective as it will improve the already available methods. For instance, even if a man refuses to use condoms, the woman will somehow be protected by using the microbicide gel. (Nakuru non-HTC provider)

I am looking at it so positively because, as you know, female clients are not able to negotiate about safe sex. And if this microbicide gel will really prevent HIV, I find it being a plus. . . . The effect is that they will find they have options in preventing, in taking care of their status—unlike with the condom. Like I said earlier, the condom is normally seen as a male thing. So the male is the one who takes charge of the use of the condom. But for the microbicide, the woman is the one who takes charge. (Nairobi HTC provider)

The vast majority of providers expressed particular interest in the HIV prevention benefit of microbicides. For these providers, HIV was seen as “the major concern most of our clients have. . . . So if they feel that maybe the microbicide is going to help minimize that risk of getting exposed, then they are bound to use it” (Nairobi HTC provider). However, most providers also expressed interest in the non-HIV related benefits of microbicides, including the potential for increased lubrication and sexual pleasure, as well as female empowerment. As one provider noted: “[Our clients] will like the enjoyment part of it—that is, it gives them pleasure during their sex. Most of them will be happy with that” (Nairobi non-HTC provider).

Although the majority of providers reported that they counsel a wide range of clients, including female sex workers, youth, married women, and couples, they most often suggested that young, single women and female sex workers would be the most interested in using microbicides. Providers explained that these groups “don’t persistently use the condoms; if they have the gel, I think that will help” (Nairobi non-HTC provider).

Only a handful providers thought married women would be interested in and could benefit from using microbicides, even if the women were HIV-negative and living in serodiscordant relationships. Most acknowledged married women as strictly unable to negotiate condom use: “[married women are] those people you are explaining to about the condoms and they tell you there is this and this and this [excuse]” (Nairobi non-HTC provider). Similarly, providers noted that these women may “want to have a child so they are not using condoms” (Nairobi HTC provider). However, providers did not appear to recognize that the non-HIV prevention benefits of microbicides, such as increased sexual pleasure, could serve as a way to negotiate microbicides, regardless of condom use, nor did they consider covert use of microbicides by married women.

Moreover, despite recognizing that many women either do not use condoms at all, or do not use them consistently, roughly half of all providers interviewed expressed some concern when discussing the hierarchy of risk. These providers were primarily concerned about the potential for risk disinhibition or condom migration, and they noted that microbicide introduction could potentially “destabilize condom promotion,” lead to “reckless sex,” or “self-sabotage.” This was particularly concerning to them, not only because of the increased potential for HIV acquisition but also because the Kenya Ministry of Health, local clinics, and partners have worked hard to popularize and destigmatize condom use. The following are illustrative quotes:

I’m looking at it as something that will destabilize all that has been put down in terms of prevention of HIV transmission. . . . I’m seeing by the end of the day, many women will not use condoms and men will prefer to go for this [microbicides]. In the process, the condom may lose value, yet it has been a very good something . . . (Nakuru HTC provider)

Microbicides is a double-edged sword. The reason why I say that is, on one side, it can really help in preventing HIV infection. But on the other side, you find that there are those who might not get this information the right way and they might use this microbicide as a way of being reckless with their sexual lives. So I feel strongly that as much as we are trying to introduce this, then we really have to be keen on the way we disseminate that information. (Nairobi HTC provider)

There is a place here where it [the flip chart] is saying that the gel will only be effective at 40%. If I tell my clients that maybe the gel will protect at 40%, then already that’s like self-sabotage. (Nairobi non-HTC provider)

Providers also expressed other concerns related to potential product introduction. Most providers raised concerns about microbicide insertion. Some felt that the insertion process would be “cumbersome” or “messy.” Others indicated that their clients might be uncomfortable with the idea and/or process of vaginal gel insertion. While most spoke generally, some thought young women, in particular, would be most uncomfortable with insertion. Nearly a third of providers also raised concerns about women potentially reusing an unhygienic insertion applicator, while others expressed concern about the potential for the gel to leak out of the vagina after insertion.

Regarding product usage, some providers expressed concern that women may wish to share the gel with their friends or family members, regardless of the fact that users will likely need to be regularly tested for HIV and properly counseled on microbicide use. For example, one provider described a potential situation involving female sex workers: “You find one of your colleagues has forgotten hers; you can put some of yours for her to use” (Nairobi non-HTC provider).

Roughly half of all providers expressed concern about gel storage. Most indicated that storing the gel in a secure location, away from curious children, would be a challenge for some women. A few providers also expressed some concern that their clients may not be able to keep the gel in a cool, dry place. This is highlighted in the following quote:

Keep the gel in a cool dry place . . . you know our community here where we live? Slum all over. You will see the gel being placed even on the bed, just next to the iron sheets; it can even melt because of the heat, but all in all, we will just explain. I’m just trying to see our set-up. But, I think these are easy things they can be able to avoid. (Nairobi HTC provider)

Some providers expressed concerns about the safety of vaginal microbicide gel. Most of these were providers from non-HTC facilities who expressed general concerns about product safety, including product composition. Similarly, a few providers were specifically concerned about the safety of gel use by pregnant women. For example, a family planning provider from Nairobi commented, “Maybe a client comes . . . and maybe she is pregnant and she wants to use that microbicide gel. What do we do?” (Nairobi non-HTC provider). Although less common, concern was also raised about HIV-positive women wishing to use the gel. A couple of providers indicated that HIV-positive women may wish to use the gel to protect their male partners from infection, while a couple others thought that HIV-positive women may either wish to use the gel to protect themselves from herpes or from reinfection with HIV, both common concerns among positive women.

Integration Into Existing Clinic Environment and Flow

In addition to promoting accurate knowledge of and favorable attitudes toward microbicides, it is critical that microbicide materials and counseling be seamlessly integrated into existing clinic environments. To this effect, we asked providers whether and how they might use the informational brochure in their clinics. Most providers reported they would likely hand the brochures out during counseling sessions or make them available in the waiting room. However, a couple of providers were concerned that a few of the images may be inappropriate for children accompanying their mothers to the clinic, even if by chance encounter. These providers were, therefore, not comfortable with the idea of leaving the brochure in their waiting rooms, preferring instead to keep the brochures for counseling sessions only.

Providers were shown one of two counseling algorithms, depending on their facility type. Most providers thought that the counseling algorithm they were shown fit within the current guidelines and practices of their facility. This was true of providers from half of HTC facilities and almost three-fourths of non-HTC facilities. Providers at HTC facilities appreciated that microbicide introduction could be integrated into their current counseling procedures of discussing prevention options immediately following risk assessment. For example, one provider noted: “It fits well. We also test after risk assessment” (Nakuru HTC provider). Similarly, a provider from a non-HTC facility felt that the non-HTC algorithm was beneficial because, in non-HTC settings, “after the client has known about the product, is when you ask about testing. I think it’s good for the client because she has known everything” (Nairobi non-HTC provider).

However, a handful of providers from a range of facilities felt that the algorithm they were shown did not fit their clinic practices. Their reasons were varied but included the need to be flexible during the counseling session (i.e., the use of an algorithm would limit their ability to be flexible); and a bias that microbicides should only be introduced to those who consistently demonstrate an ability to use condoms (i.e., believing that microbicides should only be used in combination with condoms).

Most providers felt that microbicide counseling sessions could be integrated into existing clinical protocols and that only one session would be needed to cover the topics outlined in the flip chart. Although most of these providers did not elaborate on why, nearly all acknowledged that the HIV risk assessment questions in the flip chart were similar to those they already asked as part of their clinical protocols. To avoid unnecessary repetition, providers suggested they would likely integrate and merge the two sets of questions. Therefore, for these providers, adding microbicide information into their counseling sessions would reportedly not require much additional work: “As I counsel my clients on other things, I will also counsel on microbicides” (Nairobi non-HTC provider).

However, despite alignment with clinical flow and overlap in risk assessment questions, some providers insisted that microbicide counseling could not or should not be provided in one session, given the large quantity of information to be conveyed and discussed. Their reasons primarily included the perception that there was simply too much material to cover.

It can be hard, if there are many questions. It can take a long time for others who also want to see the counselor. (Nairobi HTC provider)

One session? People will sleep in the room! (Nakuru non-HTC provider)

Providers were also asked how easy they thought it would be for their clients to return to the health facility for follow-up counseling and a resupply of gel. Most providers felt that it would be easy for their clients to return if they had any concerns about gel usage; they trusted their partners and felt free to return; they had been appropriately counseled on the benefits of the gel; and/or they had been given or texted appointment reminders.

The few providers who felt their clients would have trouble returning to the facility for follow-up counseling indicated that follow-up rates would likely depend on the client’s own experience with microbicides. For example,

How did it react with them? How was the partner? Because if the partner doesn’t support that, the client may never come again, or may opt to go to a place where they are getting adherence counseling, but not for microbicides. (Nakuru non-HTC provider)

Appropriate Client-Tailored Counseling

Provider interviews revealed some evidence of rote counseling tendencies, in which providers typically counseled young women to be abstinent, female sex workers to use condoms, and married women to be faithful. By using hypothetical counseling scenarios, we sought to uncover more nuanced counseling techniques. During these scenarios, the vast majority of providers reported that they would be comfortable suggesting microbicides to women who were unable to use condoms. All but one provider were able to properly assess the HIV risk of the woman in their assigned scenario, and most providers were also able to suggest appropriate, realistic and tailored HIV prevention options.

For example, with young or single women, including female sex workers, providers tended to suggest microbicide gel and condom use. However, if the scenario mentioned that the women had a difficult time using condoms with their partner(s), providers typically suggested that the women use microbicides alone and/or in combination with other HIV prevention strategies such as HIV testing, partner reduction, or, where possible, abstinence. The following provide illustrative quotes:

Use of condoms . . . consistently. If the partner doesn’t want to use, she (Lucy) could use the female condom. You can introduce microbicides to her. (Nakuru non-HTC provider)

Realistic for her . . . we could talk about reducing the number of partners, and also having herself tested, because she (Leila) has not been tested recently. She doesn’t even know her status in the first place, so she should be tested, get to know her HIV status. Then, if she is negative for HIV, we will be talking about reduction of sex partners, . . . persistent use of the condom and now, the gel. (Nairobi HTC provider)

A minority of providers demonstrated challenges in suggesting appropriate HIV prevention options for the women in their assigned scenarios. For example, a few providers who received scenarios about young, single women or female sex workers either failed to suggest microbicide gel or condoms as potentially appropriate prevention methods. Similarly, only a minority of those who received scenarios about married women or women in stable relationships failed to suggest that microbicide gel was potentially appropriate within those scenarios; these providers suggested instead that condom use was realistic. This was noted in the following quote:

Rosemary has a stable partner . . . so that to me is a preventive measure . . .

So if she was your client, which HIV prevention options will you give to her that is realistic?

Of course, condom-use. (Nairobi non-HTC provider)

Discussion

Overall, providers had a favorable view of both microbicides and the communication materials. Providers recognized that microbicides could have a positive impact on HIV prevention among women in Kenya. Furthermore, providers not only felt that microbicide use would be feasible for most women, but during hypothetical counseling scenarios, they were also largely competent in assessing HIV risk and suggesting appropriate prevention options, including microbicide use alone for those women who are not able to use condoms, and dual use of microbicides and condoms for women who are able to use condoms. Given that providers will play a key role in promoting product uptake and adherence, their favorable opinions and appropriate counseling techniques suggest a potentially supportive health care environment for microbicide or other similar ARV-based prevention introduction.

However, some providers ran into challenges when trying to accurately describe the BAT 24 regimen and other use instructions. And despite a general understanding of partial protection, some providers remained concerned about the low level of microbicide effectiveness and the potential for condom migration, while others expressed some concern about product safety. For new product introduction to be successful, information on partial effectiveness, use and safety will need to be clearly addressed in both the communication materials and in provider training activities. Including information on why HIV testing is required and whether the product can be used during pregnancy might also be helpful.

The majority of providers felt that the communication materials developed through this project were conducive to their clinic environments. In particular, the HIV risk assessment questions were very similar to what providers are currently required to ask and nearly all providers thought the questions could be easily integrated into their counseling sessions. The fact that many providers also felt that microbicide counseling could be conducted within existing time constraints is encouraging, especially considering the challenging workloads many Kenyan providers face.

However, we acknowledge that materials themselves cannot ensure effective counseling; rather, supportive training and supervision will be necessary throughout. Supportive clinic environments will also be necessary to motivate providers to: promote microbicides or other ARV-based prevention options to all women at risk of HIV; appropriately use the communication materials; and ensure products are kept in-stock and on-site.

Limitations to this study include the fact that vaginal microbicide gel has not yet been proven effective and is therefore not yet available for use. Consequently, the interviews were based on the discussion of a hypothetical product with many current unknowns, including final information on product use and effectiveness, as well as branding, cost, and accessibility. Moreover, although the communication materials were delivered to health facilities several days in advance of the scheduled interview date, many providers were unable to review the materials ahead of time; this may have negatively affected providers’ ability to demonstrate accurate understanding of microbicides and/or the communication materials. It also highlights the busy nature of providers’ schedules and the challenge they will face in fully counseling clients about microbicides or other ARV-based prevention products within their clinical contexts. Similarly, despite following an interview guide, the conversational nature of the interviews meant that some providers were not asked each individual question outlined in our guides. And finally, due to resource limitations, this project did not develop a training guide for providers. At the point of new product licensure and availability in Kenya, policy makers and program implementers will need to ensure providers are well trained and well equipped prior to product introduction.

After analyzing the results from this assessment, we made efforts to address major concerns raised by providers by conducting one final round of edits to the materials. However, the materials will require additional revisions once we have an available product, and provider training will also be necessary to ensure all providers have adequate understanding of new product effectiveness, proper use, and adherence issues. Although results from the FACTS 001 trial in 2015 did not confirm effectiveness of the tenofovir-based BAT 24 regimen, additional and similar products continue to advance. Consequently, countries may wish to adapt or replicate our process to support their own future communication strategies. To facilitate that process, we developed a Microbicide Communication Strategy and Adaptation Guide that, along with all final, evidence-based materials, can be found on FHI 360’s website (http://www.fhi360.org/projects/communicating-about-microbicides-women-mind).

Conclusion

As new HIV prevention products are proven effective and introduced into health care settings, health care providers will be at the forefront of facilitating product acceptability and adherence. The microbicide communication materials developed by the Communicating about Microbicides with Women in Mind project were well received and effective in educating providers about microbicides and in helping them provide appropriate counseling for hypothetical scenarios involving women in different sexual contexts.

Footnotes

Acknowledgements

We would like to thank our project advisory committee organizations: Kenya National AIDS and STI Control Programme (NASCOP); Department of Health Promotions; Reproductive and Maternal Health Services Unit (Formerly Division of Reproductive Health; National AIDS Control Council (NACC); Kenya Medical Research Institute (KEMRI); Family Health Options Kenya (FHOK); International AIDS Vaccine Initiative (IAVI); LVCT (Formerly Liverpool VCT); National Organization of Peer Educators (NOPE); Network of People living with HIV and AIDS in Kenya (NEPHAK); PS Kenya; Sex Workers Outreach Program (SWOP). We would also like to thank Artful Eyes Productions in Nairobi for diligently developing the materials.

Authors’ Note

The contents of this article do not necessarily reflect the views of USAID or the U.S. Government, the funding agencies.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID). Financial assistance was provided by USAID to FHI 360 under the terms of the Preventive Technologies Agreement No. GHO-A-00-09-00016-00.

References

Abdool Karim

S. S.

Frohlich

J. A.

Grobler

A. C.

Baxter

Mansoor

L. E.

(2010). Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science, 329, 1168-1174. doi:10.1126/science.1193748

AVAC. (2016). HIV prevention research and development database. Retrieved from http://www.avac.org/pxrd

Corneli

A. L.

Deese

Wang

Taylor

Ahmed

Agot

. . . van Damme

(2014). FEM-PrEP: Adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. Journal of Acquired Immune Deficiency Syndromes, 66, 324-331. doi:10.1097/QAI.0000000000000158

Joint United Nations Programme on HIV/AIDS. (2013). Global report: UNAIDS report on the global AIDS epidemic. Geneva, Switzerland: Author.

Marrazzo

J. M.

Ramjee

Nair

Palanee

Mkhize

Nakabilito

. . . Chirenje

(2013). Preexposure prophylaxis for HIV in women: Daily oral tenofovir, oral tenofovir/emtriciabine, or vaginal tenofovir gel in the VOICE study (MTN 003). Paper presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Atlanta, GA.

Mastro

T. D.

Sista

Abdool-Karim

(2014). ARV-based HIV prevention for women: Where we are in 2014. Journal of the International AIDS Society, 17(3 Suppl. 2), 19154. doi:10.7448/IAS.17.3.19154

Rees

Delany-Moretlwe

S. A.

Lombard

Baron

Panchia

Myer

. . . Gray

(2016). FACTS 001 Phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. Paper presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA.

Ryan

Bockh

Tolley

E. E.

Pack

A. P.

Mackenzie

Olawo

Githuka

(2015). Positioning microbicides for HIV prevention in Kenya: A case study. Social Marketing Quarterly, 21, 100-114.

Sidibe

Pack

A. P.

Tolley

E. E.

Ryan

Mackenzie

Bockh

Githuka

(2014). Communicating about microbicides with women in mind: Tailoring messages for specific audiences. Journal of the International AIDS Society, 17(3 Suppl. 2), 19151. doi:10.7448/IAS.17.3.19151

10.

Tolley

E. E.

Allison

Field

Ryan

Bockh

Mackenzie

. . . Githuka

(2014). Assessing the impact of message framing on microbicide acceptability. Paper presented at the Research for Prevention (R4P) Conference, Cape Town, South Africa.