Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03547739
Study type Interventional
Source University of Alabama at Birmingham
Contact Janet M Turan, PhD, MPH
Phone 2059346780
Email jmturan@uab.edu
Status Not yet recruiting
Phase N/A
Start date February 1, 2019
Completion date April 30, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03069417 - Support for Perinatal Adherence and Depression N/A
Completed NCT02812329 - Intervention to Encourage HIV Testing and Counseling Among Adolescents Phase 1
Completed NCT02516930 - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China N/A
Completed NCT02651376 - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients Phase 1/Phase 2
Recruiting NCT01792570 - DRV/r + RPV QD: Efficacy and Toxicity Reduction Phase 3
Recruiting NCT02392884 - HIV Medication Adherence in Underserved Populations N/A
Recruiting NCT01778374 - Mater-Bronx Rapid HIV Testing Project. N/A
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT01490346 - Tissue Drug Levels of HIV Medications N/A
Completed NCT01460433 - Problems With Immune Recovery in the Gut Tissue N/A
Completed NCT01076179 - Kaletra in Combination With Antiretroviral Agents N/A
Completed NCT00317460 - Buprenorphine and Integrated HIV Care Phase 4
Active, not recruiting NCT02919306 - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults Phase 1/Phase 2
Recruiting NCT03254277 - 3BNC117-LS First-in-Human Phase 1 Study Phase 1
Terminated NCT01692236 - Brain Imaging for HIV-Associated Thinking and Mood Disorders
Not yet recruiting NCT03231358 - Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa Phase 3
Not yet recruiting NCT02531295 - Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study Phase 1
Recruiting NCT03408262 - Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women Phase 1
Recruiting NCT01976715 - Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy
Recruiting NCT02648516 - Safety and Efficacy of Allogenic Adoptive Immune Therpy for Immune Reconstitution in Chronic HIV-1 Infected Patients Phase 1/Phase 2