An interventional study of Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies and Public Sector (PS) Health Facilities TB/HIV Integration Strategies in HIV, sponsored by Columbia University. Completed at 5 sites in Lesotho. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
MF Cohort Inclusion Criteria:
MF Cohort Exclusion Criteria:
PS Cohort Inclusion Criteria:
PS Cohort Exclusion Criteria:
Health Care Provider Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
Also known as: MF intervention
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
Also known as: Control Condition (PS)
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.
Time frame: 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.
Time frame: Up to 3 weeks after 9-month interview
CD4 count at enrollment
CD4 count at enrollment in care, collected from medical records.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 weeks after 9-month interview
Proportion of participants completed IPT among those who initiated IPT
IPT completion, collected from medical records.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 9 months post baseline interview
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
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.
Access criteria: Some data will be publically available.
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