Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to support safer conception, despite ~40% of HIV+ women in sub-Saharan Africa (SSA) becoming pregnant post HIV diagnosis. About half of these pregnancies are planned, highlighting the need for safer conception counseling (SCC) as over half of HIV-affected couples in Uganda are serodiscordant, while the unplanned pregnancies reveal a high unmet need for effective contraception. Antiretroviral therapy (ART) greatly reduces the transmission risks associated with childbearing, but many PLHA are either not on ART or not adequately adherent; hence the need for using safer conception methods (SCM) such as manual self-insemination (MSI) and timed unprotected intercourse (TUI). Transforming FP programs through the integration of SCC is not only important for promoting safer conception, but may also be key to reducing unwanted pregnancies, as well as increased PMTCT uptake, adherence and retention, as open consultation about childbearing promotes informed decisions regarding childbearing, access to contraceptives, and can limit clients feeling the need to disengage from HIV care when pregnant due to fear of childbearing-related stigma. Drawing on an ecological adaptation of the Information Motivation and Behavioral skills (eIMB) model, we developed and piloted a structured SCC intervention with 42 serodiscordant couples, 33 (79%) of whom correctly used TUI or MSI as instructed; there were 7 pregnancies and no partner seroconversions. An additional 43 couples were eligible but after the initial SCC consultation, and discussion of the risks and benefits involved, decided not to further pursue childbearing and were referred for contraceptive services. Building on this evidence of preliminary feasibility and acceptance of the intervention, and support for a comprehensive FP approach that uses open childbearing consultations to ensure that clients receive SCC and PMTCT, or contraception services, to achieve their desired reproductive goals, the proposed cluster RCT will compare (1) a comprehensive FP program that incorporates a structured, multi-component SCC intervention (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at nine HIV clinics operated by TASO Uganda. The 3-arm design, together with the planned cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP services that differ on level of intensity, thereby informing MoH policy and resource allocation. Sixty clients in serodiscordant relationships who express childbearing desires at recruitment will be enrolled at each site (n=540) and followed for 12 months or completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those trying to conceive) or dual contraception (those who decide against pregnancy).

Public Health Relevance

This study is important to public health as it seeks to evaluate and establish an approach for provision 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 #
5R01HD090981-04
Application #
9743639
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Popkin, Ronna
Project Start
2016-09-23
Project End
2021-06-30
Budget Start
2019-07-01
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