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

Study Overview
=================
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.

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

Conditions
-----------------
HIV

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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miner-Friendly (MF) Cohort<br>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<br>* 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)<br>* Other names: MF intervention;|
| Active Comparator: Public Sector (PS) Cohort<br>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<br>* 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<br>* 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) | 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) | 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 | CD4 count at enrollment in care, collected from medical records. | Up to 3 weeks after 9-month interview | 
| Time to ART initiation | 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 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 | 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 | Viral suppression, collected from medical records. | Up to 3 weeks after 9-month interview | 
| Proportion of participants completed IPT among those who initiated IPT | 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 | 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 | 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 | Participants will complete interviewer-administered questionnaires to assess IPT adherence. | Up to 9 months post baseline interview |