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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2024-10-23

Brief Summary

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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.

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Detailed Description

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Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention 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. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p\<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home visits

Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.

Group Type ACTIVE_COMPARATOR

Home visits

Intervention Type BEHAVIORAL

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.

HIV Self-testing

Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.

Group Type ACTIVE_COMPARATOR

HIV Self-testing

Intervention Type BEHAVIORAL

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.

Standard Care

Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women at 36 weeks of pregnancy or less
* 15 years of age or older
* Has been offered HIV testing at ANC
* Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
* Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
* Not in an HIV-positive concordant relationship.

Exclusion Criteria

* Greater than 36 weeks of pregnancy
* Less than 15 years of age
* Not currently in a stable relationship with a male partner
* Does not currently live with male partner
* Has not been offered HIV testing at ANC

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes