Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study
Authors: Matthews Lynn T , Psaros Christina , Mathenjwa Mxolisi , Mosery Nzwakie , Greener Letitia Rambally , Khidir Hazar , Hovey Jacquelyn R , Pratt Madeline C , Harrison Abigail , Bennett Kara , Bangsberg David R , Smit Jennifer A , Safren Steven A 
Published: March 2022

Background
Many men with HIV (MWH) want to have children. HIV viral suppression minimizes sexual HIV transmission risks while allowing for conception and optimization of the health of men, their partners, and their infants.

Objective
This study developed and evaluated the feasibility and acceptability of an intervention to promote serostatus disclosure, antiretroviral therapy (ART) uptake and adherence, and viral suppression among MWH who want to have children in South Africa.

Methods
We developed a safer conception intervention (Sinikithemba Kwabesilisa or We give hope to men) to promote viral suppression via ART uptake and adherence, HIV serostatus disclosure, and other safer conception strategies for MWH in South Africa. Through 3 counseling and 2 booster sessions over 12 weeks, we offered education on safer conception strategies and aided participants in developing a safer conception plan. We recruited MWH (HIV diagnosis known for >1 month), not yet accessing ART or accessing ART for <3 months, in a stable partnership with an HIV-negative or unknown-serostatus woman, and wanting to have a child in the following year. We conducted an open pilot study to evaluate acceptability based on patient participation and exit interviews and feasibility based on recruitment and retention. In-depth exit interviews were conducted with men to explore intervention acceptability. Questionnaires collected at baseline and exit assessed disclosure outcomes; CD4 and HIV-RNA data were used to evaluate preliminary impacts on clinical outcomes of interest.

Results
Among 31 eligible men, 16 (52%) enrolled in the study with a median age of 29 (range 27-44) years and a median time-since-diagnosis of 7 months (range 1 month to 9 years). All identified as Black South African, with 56% (9/16) reporting secondary school completion and 44% (7/16) reporting full-time employment. Approximately 44% (7/16) of participants reported an HIV-negative (vs unknown-serostatus) partner. Approximately 88% (14/16) of men completed the 3 primary counseling sessions. In 11 exit interviews, men reported personal satisfaction with session content and structure while also suggesting that they would refer their peers to the program. They also described the perceived effectiveness of the intervention and self-efficacy to benefit. Although significance testing was not conducted, 81% (13/16) of men were taking ART at the exit, and 100% (13/13) of those on ART were virally suppressed at 12 weeks. Of the 16 men, 12 (75%) reported disclosure to pregnancy partners.

Conclusions
These preliminary data suggest that safer conception care is acceptable to men and has the potential to reduce HIV incidence among women and their children while supporting men’s health. Approximately half of the men who met the screening eligibility criteria were enrolled. Accordingly, refinement to optimize uptake is needed. Providing safer conception care and peer support at the community level may help reach men.

Trial Registration
ClinicalTrials.gov NCT03818984; https://clinicaltrials.gov/ct2/show/NCT03818984

International Registered Report Identifier (IRRID)
RR2-https://doi.org/10.1007/s10461-017-1719-4