NCT05092997

Kingasa Pilot Study

Completed NA Last updated 18 July 2022

What this trial tests

NA trial testing POC viral load testing in HIV in 151 participants. Completed in 30 June 2022.

Timeline

17 February 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	health services research
Enrollment	151
Start date	17 February 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across Uganda

Drugs / interventions tested

• POC viral load testing
• Wellness visit services for male partners

Conditions studied

• HIV — all drugs for HIV →
• Linkage to Care — all drugs for Linkage to Care →
• PMTCT — all drugs for PMTCT →
• PrEP — all drugs for PrEP →

Sponsor

University of Washington

Who can join

18 and older, any sex, with HIV or Linkage to Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. "<i>It Soothes Your Heart</i>": A Multimethod Study Exploring Acceptability of Point-of-Care Viral Load Testing among Ugandan Pregnant and Postpartum Women Living with HIV.
   Nakyanzi A, Naddunga F, Bulterys MA, Mujugira A, et al · · 2023 · cited 5× · PMID 38201381 · DOI 10.3390/diagnostics14010072
2. POC Viral Load Testing in an Antenatal Clinic Setting for Ugandan Pregnant Women Living with HIV: An Implementation Process Analysis.
   Ware NC, Wyatt MA, Nakyanzi A, Naddunga F, et al · · 2024 · cited 1× · PMID 39896214 · DOI 10.1007/s44250-024-00103-8