N/A
N=1,600
Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT03547739 ↗Enrolled (actual)
1,600
Serious AEs
3.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum — 114; 106; 26 Couples tested for HIV as a couple (=Y) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home visits (Behavioral); HIV Self-testing (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum |
114; 106; 26 | <0.001 sig |
| SECONDARY HIV Re-testing |
338; 367; 258 | .001 sig |
| SECONDARY Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only) |
9; 2 | — |
| SECONDARY Number of New Discordant Couples (Intervention Arms Only) |
93; 35; 0 | — |
| SECONDARY HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum |
31; 28; 28 | — |
| SECONDARY Women Who Utilized All 4 MCH Services up to 3 Months Postpartum |
116; 103; 91 | — |
| SECONDARY Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) |
47; 49; 46 | — |
| SECONDARY Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum |
4; 1; 1 | — |
| SECONDARY Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up |
151; 165; 159 | — |
| SECONDARY Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up) |
73.9; 71.8; 71.3 | — |
| SECONDARY Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up) |
4.7; 4.7; 4.7 | — |
| SECONDARY Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum |
2; 1 | — |
| SECONDARY Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up |
14; 6; 17 | — |
| SECONDARY Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum) |
70.7; 66; 65 | — |
| SECONDARY Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum) |
3.2; 2.4; 2.9 | — |
| SECONDARY Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up) |
117; 124; 114 | .011 sig |
| SECONDARY HIV-free Child Survival |
130; 141; 142 | 0.087 |
| SECONDARY Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum |
1; 1; 0 | — |
| SECONDARY Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up) |
6.6; 6.3; 6.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03547739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.