Clinical trial NCT05092997: Kingasa Pilot Study
Official title: Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda (Kingasa Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Linkage to Care
PMTCT
PrEP
ART Adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Harvard University
First posted: 2021-10-26
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Male partner HIV testing
timeFrame: 6 months from female partner enrollment
measure: Viral suppression
timeFrame: 6 months post-partum
measure: Male partner linkage
timeFrame: 6 months from female partner enrollment
measure: Acceptability evaluation
timeFrame: One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Disease Institute
Study officials:
References: