Kingasa Pilot Study

Not Applicable

Completed

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

• Registration Number: NCT05092997
• Lead Sponsor: University of Washington

Brief Summary

In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same-day ART adherence counseling and those randomized to receive lab-based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.

Detailed Description

In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same day ART adherence counseling and those randomized to receive lab based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.

Women in both arms will receive counseling to minimize social harms associated with status disclosure and HIV testing, and additional counseling and referral to social support services when social harms occur. Based on the current Ugandan MOH guidelines to offer HIVST to both HIV-positive and HIV-negative pregnant women in ANC clinics, women in both arms will be provided an HIVST to give to their partner if they choose. They will be trained in the use and interpretation of the HIVST and be given information about HIV testing and prevention and care services, which she will give to her partner.

This study has been designed to address the gap in male partner engagement by using innovative methods to link men to HIV testing, prevention and care, and thus PMTCT outcomes for women.

Study Timeline

• Study Start: 2021-02-17
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-26
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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 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 intervention/male intervention arm	Wellness visit services for male partners	Women will be provided an invitation letter for male partners invitation letter for male partners for wellness visits and POC viral load testing 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	POC viral load testing	Women will be provided an invitation letter for male partners 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 HIV testing	6 months from female partner enrollment	To determine the proportion of male partners of pregnant HIV-positive women who test for HIV at the clinic, based on invitation to a wellness visit (dual syphilis and HIV rapid test, blood pressure, visual acuity screening and COVID symptom screening, and if available, PCR testing for those with symptoms) compared to the standard of care (standard of care invitation letter for HIV fast track testing at the clinic).
Viral suppression	6 months post-partum	To compare viral suppression (defined as less than 50 copies/mL) at 6 months post-partum among women in the intervention arm (receiving POC viral load testing and same-day ART adherence support) to women in the control arm (receiving stand of care lab-based HIV VL testing).
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.
Acceptability evaluation	One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men	To evaluate acceptability and preferences for HIV testing and other health services among 15 pregnant women and 15 male partners using qualitative in-depth interviews.

Trial Locations

Locations (1)

Infectious Disease Institute; 🇺🇬 Kampala, Uganda