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

Phase

N/A

Condition

Hiv

Treatment

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

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

Clinical Study ID

NCT03537872

AAAR3789

U01GH002115

Ages > 15
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

MF Cohort Inclusion Criteria:

Tested HIV-positive at MF site within one week of study enrollment
Currently working or have worked in a South African mine, or are a family member of aminer (first-degree relative)
Not on ART or IPT prior to testing HIV positive at the study site within the past week
No history of IPT use
15 years or older
Basotho origin
Capacity for consent

Exclusion

MF Cohort Exclusion Criteria:

Active TB
Unwilling to provide a phone number or adhere to study procedures PS Cohort Inclusion Criteria:
Tested HIV-positive at either the OPD or voluntary counseling and testing (VCT) clinicon-site within one week of study enrollment
Not on ART or IPT prior to testing HIV positive at the study site within the past week
No history of IPT use
15 years or older
Basotho origin
Capacity for consent PS Cohort Exclusion Criteria:
Tested HIV-positive at other points of service, including antenatal clinic, labor &delivery, and TB clinics
Active TB
Unwilling to provide a phone number or adhere to study procedures Health Care Provider Inclusion Criteria:
15 years or older
Health care provider in MF or PS site
Worked in the clinic for at least 3 months
Capacity for consent

Study Design

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

March 13, 2018

December 31, 2019

Study Description

TB is the most common opportunistic infection and a leading cause of death among people living with HIV (PLHIV). Early ART and IPT have been shown to reduce TB incidence, morbidity, and mortality among PLHIV, including those with high CD4 counts, and are recommended by the World Health Organization (WHO) as core strategies to reduce the burden of TB among PLHIV. Basotho migrant miners, who travel between their homes in Lesotho and work in South African mines, and their families are at elevated risk of HIV and TB, however, their testing, engagement, and retention in care and treatment are suboptimal. Implementation science research is urgently needed to determine an effective strategy for improving early detection of HIV and early initiation of ART and IPT among migrant miners and their families.

The PROMISE study is a mixed-methods implementation science study that will evaluate a miner-friendly intervention strategy to implement early ART and concurrent IPT for PLHIV. The study will assess the effectiveness, feasibility, and acceptability of integrated TB/HIV services for migrant miners and their family members provided in miner-friendly service venues (MF).

A prospective cohort study design will be used to evaluate the effectiveness of family-focused, integrated TB/HIV services for Basotho migrant miners and family members provided six days per week in miner-friendly service venues, compared to public sector health facilities (PS), which will deliver usual integrated care for the management of TB and HIV. All participants will be assessed at the time of HIV testing (baseline), and at months 3, 6, and 9.

Through implementing and measuring this enhanced TB/HIV service delivery model for miners and their families, study findings will have important implications on programs and policies broadly for PEPFAR, and specifically in Lesotho, for the organization and delivery of integrated TB/HIV services to migrant miners and their families. Findings will inform the development of more tailored interventions to promote HIV diagnosis, early ART, and IPT among miners with HIV, with possible implications for other types of mobile populations; enhance scientific awareness about the unique challenges facing miners in the context of their migration and high TB/HIV co-morbidity; and guide future efforts to develop differentiated service delivery models and integrated HIV/TB services in populations with a high prevalence of HIV and TB.

Connect with a study center

Maputsoe Filter Clinic
Leribe,
Lesotho
Site Not Available
TEBA Leribe
Leribe,
Lesotho
Site Not Available
TEBA Mafeteng
Mafeteng,
Lesotho
Site Not Available
Loretto Health Center
Maseru,
Lesotho
Site Not Available
TEBA Maseru
Maseru,
Lesotho
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.