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

Not Applicable

Completed

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

• Registration Number: NCT03537872
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miner-Friendly (MF) Cohort	Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies	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.
Public Sector (PS) Cohort	Public Sector (PS) Health Facilities TB/HIV Integration Strategies	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

Primary Outcome Measures

Name	Time	Method
Proportion of newly diagnosed HIV-positive participants initiated on ART (ART Initiation)	Up to 3 weeks after 9-month interview	Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess ART initiation. This is designed to determine if participants at MF are more likely to initiate ART compared to those at PS.
Proportion of newly diagnosed HIV-positive participants on ART initiated on IPT (IPT initiation)	Up to 3 weeks after 9-month interview	Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess IPT initiation. This is designed to compare if participants on ART at MF are more likely to initiate IPT compared to those at PS.

Secondary Outcome Measures

Name	Time	Method
CD4 count at enrollment	Up to 3 weeks after 9-month interview	CD4 count at enrollment in care, collected from medical records.
Proportion of newly diagnosed HIV-positive participants initiated on ART with plasma viral load <1000 copies/ml at 6 months after ART initiation	Up to 3 weeks after 9-month interview	Viral suppression, collected from medical records.
Time to IPT initiation	Up to 3 weeks after 9-month interview	Time to IPT initiation (in days) among newly diagnosed HIV-positive participants. Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess IPT initiation date.
Time to ART initiation	Up to 3 weeks after 9-month interview	Time to ART initiation (in days) among newly diagnosed HIV-positive participants. Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess ART initiation date.
Proportion of participants completed IPT among those who initiated IPT	Up to 3 weeks after 9-month interview	IPT completion, collected from medical records.
Proportion of newly diagnosed HIV-positive participants initiated on ART retained in care at 6 and 9 months at original clinic	Up to 3 weeks after 9-month interview	ART retention, collected from medical records.
Percentage of positive IsoScreen tests at the first study visit after IPT initiation	Up to 9 months post baseline interview	Participants will submit a urine sample which will be used to perform a IsoScreen test
Percentage of total prescribed doses of IPT ingested, by self-report, averaged across study visits	Up to 9 months post baseline interview	Participants will complete interviewer-administered questionnaires to assess IPT adherence.
Percentage of total prescribed doses of ART ingested, by self-report, averaged across study visits	Up to 9 months post baseline interview	Participants will complete interviewer-administered questionnaires to assess ART adherence.

Trial Locations

Locations (5)

Maputsoe Filter Clinic; 🇱🇸 Leribe, Lesotho

TEBA Maseru; 🇱🇸 Maseru, Lesotho

TEBA Leribe; 🇱🇸 Leribe, Lesotho

TEBA Mafeteng; 🇱🇸 Mafeteng, Lesotho

Loretto Health Center; 🇱🇸 Maseru, Lesotho