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

Not Applicable

Completed

Conditions: Human Immunodeficiency Virus

Registration Number: NCT03547739

Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1600

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum	up to 12 months postpartum	Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.

Secondary Outcome Measures

Name	Time	Method
Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum)	Up to 12 months postpartum	Mean self-reported adherence to ART assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job he was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each male partner at each time point using these three items.
Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum)	Up to 12 months postpartum	Mean number of HIV care visits assessed for HIV-positive men from baseline up to 12 months postpartum.
Number of New Discordant Couples (Intervention Arms Only)	Up to 12 months postpartum	Number of new HIV serodiscordant couples identified during observation period.
HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum	Up to 18 months postpartum	Composite variable based on self-report data from women's questionnaires, coded as Y=those who were coded as Y on the three variables described below and N= those who were coded as N on one, two, or three variables described below: (1) mothers use of antiretrovirals (ARVs) (Y=those mothers who have used ARVs from baseline up to 18 months postpartum/N=those mothers who have not used ARVs at any time point between baseline up to 18 months postpartum), (2) prophylactic ARVs given to the infant (Y=those infants who were given prophylactic ARVs up to 18 months after the birth/N=those infants who were not given prophylactic ARVs at any point from birth up to 18 months after the birth), and (3) Y=if exclusive breastfeeding was practiced up to 6 months after the birth and N=if exclusive breastfeeding was not practiced up to 6 months after the birth.
HIV Re-testing	Up to 12 months postpartum	Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire.
Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)	Up to 12 months postpartum	Number of new HIV-positive test results of male partners from baseline to 12 months postpartum and coded as Y=those who had tested for HIV individually up to 12 months postpartum and N=those who had not tested for HIV individually up to 12 months postpartum.
Women Who Utilized All 4 MCH Services up to 3 Months Postpartum	Up to 3 months postpartum	Composite variable based on self-report data from women's questionnaires: Y=if all described variables coded as Y, N=if at least one of the following variables coded as N: (1) Y=if a woman completed at least four antenatal care (ANC) visits during this pregnancy, N=if a woman completed less than four ANC visits during this pregnancy; (2) Y=if a childbirth was with a skilled attendant, N=if a childbirth was not with a skilled attendant; (3) Y=if a postpartum check-up was completed for a woman and N=if the women did not have a postpartum check-up, and (4) Y=if the infant had a postnatal check-up, N=if a if a postnatal check-up was not completed for the infant. These are assessed in the follow-up questionnaires completed up to 3 months postpartum.
Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline)	Up to 18 months postpartum	Initiation of PrEP by participants with HIV-negative status at baseline, assessed at each follow-up in the questionnaires up to 18 months after the baby's birth.
Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum	Up to 12 months postpartum	Number of HIV-positive women not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive woman at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.
Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up	Up to 12 months postpartum	Woman's retention in HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive woman at baseline has not been retained in HIV up to 12 months postpartum.
Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up)	Up to 12 months postpartum	Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job she was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each woman at each time point.
Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up)	Up to 12 months postpartum	Mean number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records.
Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum	Up to 12 months postpartum	Number of HIV-positive men not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive man at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.
Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up	Up to 12 months postpartum	Men's retention in HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive man at baseline has not been retained in HIV up to 12 months postpartum.
Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)	Up to 18 months postpartum	Viral Load \< 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.
Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up)	Up to 18 months after birth	Time to first infant HIV test based on medical records. This is the number of weeks since the baby's birth to the first HIV test and is reported as a median weeks value for each study arm.
HIV-free Child Survival	18 months after the birth	Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.
Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum	Up to 18 months after birth	Number of infants of HIV-positive mothers who tested HIV+ up to 18 months postpartum based on medical records. This is be a Y/N variable with Y if the infant tested HIV+ up to 18 months postpartum and N if they did not test HIV+.