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

University of Washington

Status: Invitation-only

Conditions: Linkage to Care; HIV; ART Adherence; PMTCT; PrEP

Treatments: Diagnostic Test: POC viral load testing; Other: Wellness visit services for male partners

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05194085

1K01MH115789-01A1 (U.S. NIH Grant/Contract)

STUDY0009286-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for women:

Age ≥18 or 14-17 years if an emancipated minor (pregnant or have a child), Currently pregnant, Not currently enrolled in an HIV treatment study, Male partner not known to be HIV-positive or has not tested in the past 3 months, Able and willing to provide written informed consent, Able and willing to provide adequate locator information for study retention purposes, Screening negative for any indication of intimate partner violence or social harm

Inclusion Criteria for men:

Female partner enrolled in Kingasa pilot study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Female SOC/Male SOC arm

No Intervention group

Description:

Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing at enrollment and every 6 months until 6 months postpartum

Female intervention/Male SOC arm

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: POC viral load testing

Female SOC/Male intervention arm

Active Comparator group

Description:

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

Treatment:

Other: Wellness visit services for male partners

Female intervention/male intervention arm

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: POC viral load testing

Other: Wellness visit services for male partners