The parent grant to this application evaluates the effects of a safer conception counseling (SCC) intervention to improve accurate use of safer conception methods (SCM) and prevention of horizontal transmission for HIV serodiscordant couples in a cluster randomized controlled trial in Uganda. This revised application leverages this clinical trial to inform integration of pre-exposure prophylaxis (PrEP) into SCC for HIV serodiscordant couples considering childbearing. Family planning services for people living HIV/AIDS (PLHA) in Uganda focus on preventing unplanned pregnancies and mother-to-child-transmission, and currently provide no services to support safer conception, despite high rates of fertility desires and pregnancy among HIV serodiscordant couples. Antiretroviral therapy (ART) greatly reduces transmission risks related to childbearing, but ~40% of PLHA in Uganda are not on ART and ~30% of ART clients have poor adherence. SCC to promote use of complimentary SCM, including timed unprotected intercourse (TUI) and manual self-insemination (MSI), and now PrEP as it begins to become more readily available, is much needed. While PrEP may be a desirable form of SCM for serodiscordant couples wishing to conceive, it presents unique challenges. Gaps in knowledge exist, as just 15% were aware that ARVs could be taken by the HIV-negative partner to reduce risk in our prior research; yet, when explained, 84% believed that uninfected partners would be willing to use PrEP while trying to conceive. The broader literature on PrEP points to barriers to uptake, including fears of stigma and side effects, doubts about its efficacy, and beliefs of negative effects on fertility, but also suggests that pregnancy desires may be a facilitator of PrEP use. Nevetheless, in-depth qualitative studies exploring how PrEP may influence decision making related to childbearing and selection of SCM, identifying facilitators and barriers to uptake and adherence to PrEP as a SCM, and informing strategies to integrate PrEP into SCC are absent in the literature. With nearly half of serodiscordant Ugandan couples wanting children, this research is key to optimizing the impact of PrEP. Since July 2018, TASO, our collaborating partner in the parent grant, has provided PrEP to over 100 serodiscordant couples at one of our study sites, presenting us with the opportunity to use mixed methods with our current study sample as well as new research participants to: (1) understand individual, interpersonal and structural factors that may influence use of PrEP among serodiscordant couples with childbearing desires, including how access to PrEP and childbearing desires may influence each other; (2) identify strategies to integrate and promote PrEP in SCC programs, overcome structural barriers and promote adherence; and (3) examine client factors that influence PrEP uptake, adherence and retention. To achieve these aims, we will use qualitative interviews with clients (and willing partners) (10 couples using PreP, 10 not using PreP, and 10 who have discontinued PrEP)(n~45-60); key informant interviews with TASO leadership, trainers and providers (n~16); and quantitative analysis of TASO?s routinely collected PrEP program data.

Public Health Relevance

This study is important to public health as it seeks to evaluate and establish an approach for integrating PrEP into safer conception counseling for HIV serodiscordant couples, and in pursuit of comprehensive family planning services for people living with HIV that integrates routine childbearing discussions and safer conception counseling with existing contraception services in order to promote prevention of unplanned pregnancies, safer conception, and use of PMTCT?thereby promoting prevention of both horizontal and vertical transmission of HIV.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
3R01HD090981-04S1
Application #
9875324
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Popkin, Ronna
Project Start
2016-09-23
Project End
2021-06-30
Budget Start
2019-09-25
Budget End
2020-06-30
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Rand Corporation
Department
Type
DUNS #
006914071
City
Santa Monica
State
CA
Country
United States
Zip Code
90401