Kingasa Pilot Study

NCT05092997 | Completed

• 2 other identifiers: STUDY00009286R01MH113434
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Male partner HIV testing

  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).

  6 months from female partner enrollment

• Viral suppression

  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).

  6 months post-partum

• 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

• Acceptability evaluation

  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.

  One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men

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 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
• Harvard University: collaborator

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (1)

• Ware NC, Wyatt MA, Nakyanzi A, Naddunga F, Pisarski EE, Kyomugisha J, Birungi JE, Bulterys MA, Kamusiime B, Nalumansi A, Kasiita V, Mujugira A, Celum CL. POC Viral Load Testing in an Antenatal Clinic Setting for Ugandan Pregnant Women Living with HIV: An Implementation Process Analysis. Discov Health Syst. 2024;3:44. doi: 10.1007/s44250-024-00103-8. Epub 2024 Jun 26.

  PMID: 39896214 DERIVED

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: Professor of Global Health, Medicine, and Epidemiology

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: October 26, 2021
• Study Start: February 17, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)