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

November 20, 2023 updated by: Andrea Howard, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lesotho
      • Leribe, Lesotho
        • Maputsoe Filter Clinic
      • Leribe, Lesotho
        • TEBA Leribe
      • Mafeteng, Lesotho
        • TEBA Mafeteng
      • Maseru, Lesotho
        • Loretto Health Center
      • Maseru, Lesotho
        • TEBA Maseru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)

Other Names:
  • MF intervention
Active Comparator: 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
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
Other Names:
  • Control Condition (PS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of newly diagnosed HIV-positive participants initiated on ART (ART Initiation)
Time Frame: 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.
Up to 3 weeks after 9-month interview
Proportion of newly diagnosed HIV-positive participants on ART initiated on IPT (IPT initiation)
Time Frame: 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.
Up to 3 weeks after 9-month interview

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Centers for Disease Control and Prevention
Ministry of Health, Lesotho
National University of Lesotho (NUL)

Investigators

  • Principal Investigator: Andrea A. Howard, MD, MS, ICAP at Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AAAR3789
  • U01GH002115 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ICAP will make de-identified datasets from this project publically available, per CDC requirements.

The dataset includes: 1) Routinely collected aggregate data from all patients undergoing HIV testing, including number tested for HIV, number testing HIV-positive, and number linked to care, stratified by sex and age; 2) Data collected from cohort participants in the miner-friendly service venue (MF) and public sector facility (PS) conditions, including a baseline interview, 3-, 6- and 9-month follow-up interviews, time-motion assessments, IsoScreen test results to measure adherence to IPT, and medical record abstraction of HIV clinic records; 3) Data collected from MF participants only, including in-depth interviews with miners and family members and health care providers; and 4) Data collected from all study sites, including a monthly site assessment of program characteristics and prospective data on service delivery costs.

IPD Sharing Time Frame

Data will be available upon publication of the final report/major publication or 30 months after the completion of data collection, whichever comes first, per CDC requirements.

IPD Sharing Access Criteria

Some data will be publically available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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