CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537872
NCT03537872N/ACompleted

PROvide MIner-friendly SErvices for Integrated TB/HIV Care in Lesotho Study (PROMISE Study)

Columbia University·interventional·Posted May 25, 2018·Updated Nov 22, 2023

In Brief

A clinical study evaluating Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies and Public Sector (PS) Health Facilities TB/HIV Integration Strategies for HIV. Completed, enrolled 248 participants across 5 sites.

Detailed Summary

The PROvide MIner-friendly SErvices for Integrated TB/HIV Care (PROMISE) study will assess the effectiveness, feasibility, and acceptability of integrated tuberculosis (TB)/HIV services provided in miner-friendly service venues in Lesotho that address barriers to early HIV diagnosis and antiretroviral therapy (ART) initiation, concurrent isoniazid preventive therapy (IPT), and retention in HIV care for migrant miners and their families in the context of President's Emergency Plan For AIDS Relief (PEPFAR) programming. The study will evaluate family-focused, integrated TB/HIV services for Basotho migrant miners and family members provided six days per week in miner-friendly service venues (MF), compared to public sector health facilities (PS), which will deliver usual integrated care for the management of TB and HIV. The ultimate goals of the project are to 1) improve health outcomes among migrant miners and their families, a hard-to-reach population that represents a hotspot of TB/HIV transmission, in Lesotho and in PEPFAR programs more broadly; and 2) strengthen the implementation science research capacity of national and local institutions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesLesotho

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartMar 13, 2018
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.1 years ago

Interventions

Miner-Friendly (MF) Service Venues TB/HIV Integration Strategiesbehavioral

In addition to the control condition strategies (marked "PS"), the MF intervention includes additional strategies (marked "MF"): STRUCTURAL LEVEL Co-location of TB and HIV services (PS); Co-location of clinical and non-clinical services (MF); Demand creation (MF); Weekend service hours (MF) CLINIC LEVEL Intensified TB case finding and IPT (PS); Test and START (PS); Training for healthcare workers (PS); Job aids and mentorship for healthcare workers (MF) INDIVIDUAL/FAMILY LEVEL Health literacy for patients (PS); Family counseling (PS - limited); One-way SMS text messaging and lay counselor support for adherence and retention (MF); A menu of options for medication refills for miners unable to visit the clinic on a monthly basis (MF)

Public Sector (PS) Health Facilities TB/HIV Integration Strategiesbehavioral

STRUCTURAL LEVEL Co-location of TB and HIV services CLINIC LEVEL Intensified TB case finding and IPT; Test and START; Training for healthcare workers INDIVIDUAL/FAMILY LEVEL Health literacy for patients; Family counseling (limited); Adherence support from nurses and village health workers