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

NCT05194085 | Unknown DMC

• 2 other identifiers: STUDY0009286-A1K01MH115789-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Female SOC/Male SOC arm

NO INTERVENTION

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

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

Female SOC/Male intervention arm

ACTIVE COMPARATOR

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

Female intervention/male intervention arm

ACTIVE COMPARATOR

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; Other: Wellness visit services for male partners

Interventions

POC viral load testing DIAGNOSTIC_TEST

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.

Female intervention/Male SOC arm; Female intervention/male intervention arm

Wellness visit services for male partners OTHER

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

Female SOC/Male intervention arm; Female intervention/male intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Female partner enrolled in Kingasa pilot study.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Study Officials

• Monisha Sharma, PhD, ScM

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Global Health

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: February 17, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)