P08.01
Background: Per capita incomes (PPP) in most African countries are<$2000/year and per capita expenditures on health<$100. The cost per HIV infection averted (HIA) should be less than per capita income. These metrics should inform what interventions are appropriate to test and what local standards of care (SOC) should include. To reduce AEs and unplanned pregnancy, trials should also provide other health services.
Methods: Phase I-III trials conducted at the Rwanda Zambia HIV Research Group (RZHRG) were assessed to identify common preventable infectious diseases reported as AEs, and pregnancies. Separately, a non-RZHRG study protocol for a large phase III trail of ART treatment-as-prevention (TasP) was reviewed by a team with 25+years of HIV, development, and ethics research in Africa. SOC services were evaluated and ethical concerns were identified.
Results: In 5 RZHRG trials, malaria, helminth infections, and diarrhea were common: in one trial, 6/24 HIV- participants were diagnosed with urinary schistosomiasis. Bed nets, chlorine, hand soap, and helminth treatment could prevent most of these AEs. Contraception (FP) was provided and there were no pregancies.
In the TasP trial, the majority of participants will have a spouse. Voluntary HIV Testing and Counseling (VTC) is a trial procedure and Couples' VCT (CVCT) should also be, as recommended by WHO. The protocol refers to ‘family testing’ but this is not a prevention strategy. CVCT is associated with a reduction in new HIV infections and should be explicitly included in protocols and procedures. HIA for TasP should be compared with HIA CVCT, MC, and FP.
Conclusions: Both trials and participants would benefit from low-cost screening and treatment services for endemic diseases such as bed nets, routine deworming, soap and chlorine as well as provision of contraceptives. TasP trials should analyze costs and have a rationale for testing interventions with HIA>PPP. Excluding locally affordable HIV prevention services including CVCT from trial SOC is unethical.
