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

Columbia University

Status: Completed

Conditions: HIV

Treatments: Behavioral: Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies; Behavioral: Public Sector (PS) Health Facilities TB/HIV Integration Strategies

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03537872

U01GH002115 (U.S. NIH Grant/Contract)

AAAR3789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 a miner (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

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) clinic on-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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Miner-Friendly (MF) Cohort

Experimental group

Description:

Subjects will be enrolled over the 9-month enrollment period and will receive additional integrated strategies available at a miner-friendly service venue. Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies.

Treatment:

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

Public Sector (PS) Cohort

Active Comparator group

Description:

Subjects will be enrolled over the 9-month enrollment period and will receive the usual integrated care for the management of TB and HIV at a public sector health facility. Public Sector (PS) Health Facilities TB/HIV Integration Strategies

Treatment:

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