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

Summary

This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.

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.

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Witwatersrand, South Africa

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Janet M Turan, PhD, MPH · University of Alabama at Birmingham

• Lynae Darbes, PhD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-20

Primary Completion

2024-06-27

Completion

2024-10-23

Countries

• Kenya

Study Locations