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

NCT ID: NCT03537872

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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.

Conditions

HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Miner-Friendly (MF) Cohort

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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) Cohort

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

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)

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

MF intervention; Control Condition (PS)

Eligibility Criteria

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

• 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

• 15 years or older
• Health care provider in MF or PS site
• Worked in the clinic for at least 3 months
• Capacity for consent

Exclusion Criteria

• Active TB
• Unwilling to provide a phone number or adhere to study procedures

• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Ministry of Health, Lesotho

OTHER_GOV

Sponsor Role: collaborator

National University of Lesotho (NUL)

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Andrea Howard

Associate Professor of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea A. Howard, MD, MS

Role: PRINCIPAL_INVESTIGATOR

ICAP at Columbia University

Locations

Maputsoe Filter Clinic

Hlotse, , Lesotho

TEBA Leribe

Hlotse, , Lesotho

TEBA Mafeteng

Mafeteng, , Lesotho

Loretto Health Center

Maseru, , Lesotho

TEBA Maseru

Maseru, , Lesotho

Countries

Lesotho

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