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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PrEP; HIV; PMTCT; Linkage to Care; ART Adherence
• Intervention / Treatment: Diagnostic test: POC viral load testing; Other: Wellness visit services for male partners

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Infectious Disease Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Female SOC/Male SOC arm; 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
Active Comparator: Female intervention/Male SOC arm; 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	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.
Active Comparator: Female SOC/Male intervention arm; 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	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
Active Comparator: Female intervention/male intervention arm; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Male partner linkage	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.	6 months from female partner enrollment

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Monisha Sharma, PhD, ScM, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY0009286-A; 1K01MH115789-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No