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

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.

Conditions

• HIV

Interventions

BEHAVIORAL

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

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)

BEHAVIORAL

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

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Ministry of Health, Lesotho

  collaborator OTHER_GOV

• National University of Lesotho (NUL)

  collaborator UNKNOWN

• Columbia University

  lead OTHER

Principal Investigators

• Andrea A. Howard, MD, MS · ICAP at Columbia University

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-13

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Lesotho

Study Locations