Treatment trial for African transgender women and men who have sex with men shows successful scale-up is possible
Treatment coverage and viral suppression more than doubles in a year without a significant increase in treatment failure or drug resistance.
A 12-month HIV treatment trial for transgender women and men who have sex with men in Kenya, Malawi and South Africa saw antiretroviral treatment (ART) and viral suppression rates more than double.
Although a relatively small sample size of 64 participants, the findings show it is possible to provide effective HIV treatment in public clinics to people from both groups, despite them being criminalized and facing high levels of stigma and discrimination.
Less than a third of men living with HIV who have sex with men are on ART and viral suppression rates are low. Data on transgender women are scarce, and information on drug resistance for both groups is limited.
The HIV Prevention Trials Network (HPTN) 075 ran between 2015 and 2017 to assess the feasibility of including men who have sex with men and transgender women in future HIV prevention trials. Participants were enrolled from Kisumu in Kenya, Blantyre in Malawi, and Cape Town and Soweto in South Africa.
HPTN075 involved 400 participants, consisting of HIV-negative people and people living with HIV who were not already on treatment. Of the 70 participants living with HIV, 64 were followed quarterly for 12 months (24 were transgender women, the rest men who have sex with men).
At the start of the study, 28% began ART after testing HIV positive. After 12 months 59% were on treatment, meaning uptake had more than doubled. Treatment uptake varied widely, for example, 64% in Kenya began treatment at the study’s start compared to just 5% in Soweto.
The proportion of people who were virally suppressed also increased significantly, rising from 22% to 58%. Initial viral suppression rates were highest in Kenya at 50% and lowest in Soweto at 10%.
Both ART uptake and viral suppression had increased at all four sites after 12 months. By the end of the study, ART coverage ranged from 50% to 79%, and viral suppression between 43% and 79%. The greatest increases happened in Soweto where ART uptake increased 11-fold (from 5% to 55%) and viral suppression 6.5-fold (from 10% to 65%).
Just over 10% of participants on ART did not reach viral suppression. But this did not change between the study’s start (12%) and end (11%).
Overall, 8% of participants had drug-resistant HIV.
Eight participants had drug resistance when first screened. Of these, six were only resistance to the NNRTI class of drugs, and two had NNRTI plus NRTI resistance (read more on drug classes here). Among the four participants with drug resistance at 12 months, one had NNRTI resistance only, and three had NNRTI plus NRTI resistance. None of the participants had PI resistance.
The differences between sites may reflect local differences in HIV care. Soweto was the only site to offer HIV care on-location; the others referred people to local HIV clinics. Drug resistance testing also varied between sites, which may have impacted outcomes.
Trial staff received training on stigma reduction, cultural sensitivities, the use of ART for prevention and adherence counselling, which may have contributed to the study’s results. None of the sites offered peer-led treatment support. Had they done so it is likely the trial’s outcome would have been even higher.