Uganda has the fifth highest HIV burden globally and one of the highest fertility rates in Africa. Prevention of mother-to-child HIV transmission Option B+ (PMTCT B+) is national policy in Uganda. To maximize the prevention and clinical benefits of PMTCT B+, the challenges of low HIV testing by male partners and high rates of post-partum discontinuation of ART, insufficient adherence, and incomplete viral suppression need to be addressed. Women may be more likely to continue ART long-term and have higher adherence post-partum if their partner is tested, there is mutual disclosure of HIV status, and their partner takes ART or PrEP, depending on his status. Innovative approaches are needed to allow men to test in settings other than busy antenatal clinics, preferably where they have privacy, are comfortable and do not miss work. Innovative HIV testing technology -HIVST- could increase male partner's uptake of HIV testing, and prevention (PrEP) or ART (for all HIV-positive men). This study has been designed to address this gap through an enhanced PMTCT B+ program with HIV self-testing, and linkage to PrEP or ART, for male partners.
In a demonstration project the investigators recently completed among mutually disclosed East African HIV serodiscordant couples (the Partners Demonstration Project), integrated ART and PrEP delivery with time-limited PrEP for the HIV-negative partner as a 'bridge' until the HIV-positive partner was on ART for six months, and achieved viral suppression, was very acceptable, achieved very high uptake and adherence to ART and PrEP, and nearly eliminated HIV transmission. This protocol builds on that demonstration project by evaluating whether PMTCT outcomes are improved by increasing uptake of HIV testing and PrEP among HIV-negative men whose pregnant partner is HIV-positive. PrEP for HIV-negative male partners of HIV-positive pregnant women provides highly effective prevention benefits during an important 'season of risk' when men may have higher HIV acquisition risk from their partner if she is viremic (during the first few months after ART initiation, post-partum ART discontinuation or due to viral resistance), or from outside partners.
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women who are randomized to the HIVST arm, achieves higher uptake of their male partner's testing and linkages to HIV care and prevention among male partners, compared to invitation letters for fast track testing in the clinic (the standard of care). The investigators will recruit HIV-positive women ≥18 years accessing PMTCT B+ programs in Kampala, who have a male partner of unknown HIV status. Women will be randomized to the intervention (HIVST) or the control arm (invitation letters to deliver to partners to come for fast-track testing at the Antenatal Care (ANC) clinic where she receives care.
