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

Not Applicable

• Conditions: Linkage to Care; PMTCT; PrEP; ART Adherence; HIV
• Interventions: Diagnostic Test: POC viral load testing; Other: Wellness visit services for male partners

• Registration Number: NCT05194085
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study Start: 2021-02-17
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Female intervention/male intervention arm	POC viral load testing	Women will be provided an invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum
Female intervention/Male SOC arm	POC viral load testing	Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and POC VL tests for women at enrollment, delivery, and 6 months post-partum
Female SOC/Male intervention arm	Wellness visit services for male partners	Women will be provided an invitation letter for male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment, delivery, and 6 months post-partum
Female intervention/male intervention arm	Wellness visit services for male partners	Women will be provided an invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum

Primary Outcome Measures

Name	Time	Method
Male partner linkage	6 months from female partner enrollment	To assess the proportion of HIV-negative male partners who initiate PrEP and HIV positive men who initiate ART among male partners who test for HIV and are provided male counselor phone follow up or who receive standard of care.

Trial Locations

Locations (1)

Infectious Disease Institute; 🇺🇬 Kampala, Uganda