NCT05194085

Impact of Male Provider Phone Calls to Increase Men's Clinic Linkage After HIVST

Kingasa Study: Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT.

Detailed description

Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT. Approach: Leveraging the staff and infrastructure of an ongoing study, Kingasa (R01MH113434), this study will evaluate the impact of phone calls from a male counselor to encourage male partners to link to HIV care or prevention services after HIV testing. The intervention will provide male counselor follow-up to 100 male partners of pregnant women in the intervention arm of the Kingasa study. Exit interviews will be conducted with men and their female partners to assess acceptability and challenges associated with the intervention. Outcomes assessed include ART initiation among HIV-positive men and PrEP by HIV-negative men at 6 months. Hypothesis: The intervention of a phone call from a male counselor to provide counseling and encourage linkage to HIV care or prevention will be feasible and acceptable. It will result in a higher proportion of men linking to treatment and prevention compared to the standard of care arm of the Kingasa pilot study.

Conditions

• HIV
• Linkage to Care
• PMTCT
• PrEP
• ART Adherence

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	POC viral load testing	POC viral load testing- women randomized to have POC VL at enrollment, delivery and 6 months post-partum, will have a finger prick to obtain whole blood for the Cepheid Xpert HIV-1 RNA cartridge on the Xpert IV machine with results in 90 minutes. Women who are randomized to POC VL who have VL \>200 c/ml will receive additional adherence counseling, following the STREAM protocol, \[26\] to address the challenges that they are having with ART use. At the delivery visit, infants of women in the POC VL arm will also have viral load testing done.
OTHER	Wellness visit services for male partners	Wellness visits for men- additional prevention services for men randomized to the intervention arm, including dual syphilis and HIV testing, blood pressure, visual acuity screening, and COVID-19 screening as part of wellness

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-01-18
• Last updated: 2022-11-08

Locations

1 site across 1 country: Uganda