Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya

NACompletedINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

June 27, 2024

Study Completion Date

October 23, 2024

Conditions
Human Immunodeficiency Virus
Interventions
BEHAVIORAL

Home visits

If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.

BEHAVIORAL

HIV Self-testing

Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.

Trial Locations (1)

Unknown

Kenya Medical Research Institute, Nairobi

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

collaborator

University of Michigan

OTHER

collaborator

University of Witwatersrand, South Africa

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of Alabama at Birmingham

OTHER