Randomized Controlled Trials for HIV/AIDS Prevention Among Men and Women in Africa: Untraced Infections, Unasked Questions, and Unreported Data

Abstract

In 16 countries in sub-Saharan Africa, from 5% to 26% of adults aged 15-49 are HIV-positive. Because HIV transmits through memorable sexual or skin-piercing events, researchers working with Africans with new infections should be able to identify the risks that led to their infections and so explain how HIV transmits so extensively in Africa. But that has not happened.

Much of the research into adults’ risks for HIV in Africa has been conducted through randomized controlled trials (RCTs) of interventions to prevent HIV infections. This review identified 44 RCTs from previous reviews, searches of trial registries, and other records. These RCTs followed a total of more than 120,000 adults in Africa and observed more than 4,000 incident infections. For 10 interventions, HIV incidence was significantly lower among adults who received the intervention than among other adults. The projected impact of all apparently successful interventions on Africa’s epidemics is limited by various factors, including their promise of only partial protection, high cost, dangerous side effects, and/or conflicting information.

The major failure in these 44 RCTs is not the disappointing menu of conditionally successful interventions, but rather their failure to identify what is different about sexual and/or blood-borne HIV transmission in Africa that allows such terrible epidemics. With few exceptions, RCTs did not identify sexual partners who infected participants or report HIV incidence in participants with and without unprotected sex or skin-piercing events. Information from these 44 RCTs is thus insufficient to guide HIV prevention in Africa.

No study team has made their data available for others to analyze, and only four explain in detail the data they collected. Some procedures were ethically dubious; for example, 6 studies did not warn participants that partners had tested HIV-positive. African governments should insist on better research – thorough, open, and ethical – to explain their epidemics, and should reestablish their HIV prevention programs on complete and accurate public messages about all risks.

Keywords: HIV, AIDS, Africa, prevention, randomized controlled trials, research

JEL Classification: I10