Kingasa Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Linkage to Care PMTCT PrEP ART Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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,

Group Type NO_INTERVENTION

No interventions assigned to this group

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;

Group Type ACTIVE_COMPARATOR

POC viral load testing

Intervention Type 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 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;

Group Type ACTIVE_COMPARATOR

Wellness visit services for male partners

Intervention Type 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 intervention/male intervention arm

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.

Group Type ACTIVE_COMPARATOR

POC viral load testing

Intervention Type 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.

Wellness visit services for male partners

Intervention Type 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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes