NCT05862857

Brief Summary

This study will test innovative interventions to increase uptake and use of biomedical HIV prevention options by engaging women and men at drinking venues in rural Kenya and Uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

May 8, 2023

Results QC Date

February 2, 2026

Last Update Submit

March 9, 2026

Conditions

HIV/AIDS

Keywords

Drinking venuesBiomedical HIV preventionUgandaKenya

Outcome Measures

Primary Outcomes (1)

  • Biomedical HIV Prevention Uptake at 4 Weeks

    The proportion of HIV-negative adults, receiving an Aim 1 mobilization card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

    Measured 4 weeks after clinic screening visit

Secondary Outcomes (6)

  • Biomedical HIV Prevention Uptake at 8 Weeks

    Measured 8 weeks after clinic screening visit

  • Biomedical HIV Prevention Uptake at 12 Weeks

    Measured 12 weeks after clinic screening visit

  • HIV Testing Uptake

    Measured at clinic screening visit

  • Yield of Adults With Untreated HIV

    Measured at clinic screening visit

  • Yield of Adults With Heavy Alcohol Use

    Measured at clinic screening visit

  • +1 more secondary outcomes

Study Arms (2)

Aim 1: HIV-focused mobilization

ACTIVE COMPARATOR

Patrons and workers at drinking venues will be given a recruitment card for free HIV testing at the local clinic.

Behavioral: HIV-focused mobilization

Aim 1: Multi-disease-focused mobilization

EXPERIMENTAL

Patrons and workers at drinking venues will be given a recruitment card for free multi-disease testing at the local clinic, including: diabetes, hypertension, HIV, malaria, TB, pregnancy.

Behavioral: Multi-disease-focused mobilization

Interventions

HIV-focused mobilizationBEHAVIORAL

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free HIV testing at the local clinic

Aim 1: HIV-focused mobilization
Multi-disease-focused mobilizationBEHAVIORAL

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free health screenings that may include hypertension, diabetes, HIV, malaria (if febrile), and TB (if symptomatic), and pregnancy at the local clinic

Aim 1: Multi-disease-focused mobilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult (≥18 years)
  • patron or worker at a drinking venue within the study community

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kenya Medical Research Institute (KEMRI)

Mbita, Kenya

Location

Infectious Diseases Research Collaboration (IDRC)

Mbarara, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Gabriel Chamie
Organization
University of California
gabriel.chamie@ucsf.edu
415-476-4082

Study Officials

  • Gabriel Chamie, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 17, 2023

Study Start

July 13, 2023

Primary Completion

February 3, 2025

Study Completion

March 28, 2025

Last Updated

March 11, 2026

Results First Posted

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Per our Data Sharing agreement with the NIAAA Data Archive, we will share de-identified IPD from our baseline questionnaire, which includes questions about subject demographics, HIV risk, and alcohol use.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP).

Locations

UG(1)KE(1)