HIVPROMISENCT03537872

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

A study testing Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies and Public Sector (PS) Health Facilities TB/HIV Integration Strategies in people with HIV, run by Columbia University at 5 sites in Lesotho.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies and Public Sector (PS) Health Facilities TB/HIV Integration Strategies
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 5 sitesLesotho
Study dates: 13 Mar 2018to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Lesotho5 sites

Maputsoe Filter Clinic
Hlotse
TEBA Leribe
Hlotse
TEBA Mafeteng
Mafeteng
Loretto Health Center
Maseru
TEBA Maseru
Maseru

Other trials in Lesotho

About this study

Official title: 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.

Read the 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
Being tested: Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies, Public Sector (PS) Health Facilities TB/HIV Integration Strategies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Miner-Friendly (MF) Service Venues TB/HIV Integration StrategiesBehavioural
Also called MF intervention
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) Health Facilities TB/HIV Integration StrategiesBehavioural
Also called Control Condition (PS)
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

Study groups in NCT03537872
Study group	Role	What they receive
Miner-Friendly (MF) Cohort	Experimental	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. Receives: Behavioral: Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies
Public Sector (PS) Cohort	Active comparator	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 Receives: Behavioral: Public Sector (PS) Health Facilities TB/HIV Integration Strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to 3 weeks after 9-month interview

Secondary outcomes (9)

CD4 count at enrollment
CD4 count at enrollment in care, collected from medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 weeks after 9-month interview
Proportion of participants completed IPT among those who initiated IPT
IPT completion, collected from medical records.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 9 months post baseline interview

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201831 Dec 2019

First posted25 May 2018
Study start13 Mar 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (89)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537872
Sponsor's protocol ID: AAAR3789
Other IDs: U01GH002115
Acronym: PROMISE
Status last verified: Nov 2023
First submitted: 15 May 2018
Last updated: 22 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Lesotho Ministry of Health, ICF International. Lesotho Demographic and Health Survey 2014. Key Indicators Report. Maseru; 2015.
Global tuberculosis report 2016. Geneva, Switzerland: World Health Organization; 2016.
Howard AA, Saito S, Frederix K, Hirsch-Moverman Y, Maama LB, Tau P, et al. Integrating TB/HIV Services for Migrant Miners and Their Families in Lesotho. Conference on Retroviruses and Opportunistic Infections February 22-25, 2016. Boston. Abstract 738.
Stuckler D, Basu S, McKee M, Lurie M. Mining and risk of tuberculosis in sub-Saharan Africa. Am J Public Health. 2011 Mar;101(3):524-30. doi: 10.2105/AJPH.2009.175646. Epub 2010 Jun 1.
PubMed 20516372
Corbett EL, Marston B, Churchyard GJ, De Cock KM. Tuberculosis in sub-Saharan Africa: opportunities, challenges, and change in the era of antiretroviral treatment. Lancet. 2006 Mar 18;367(9514):926-37. doi: 10.1016/S0140-6736(06)68383-9.
PubMed 16546541
Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clin Infect Dis. 2010 May 15;50 Suppl 3:S201-7. doi: 10.1086/651492.
PubMed 20397949
Charalambous S, Grant AD, Innes C, Hoffmann CJ, Dowdeswell R, Pienaar J, Fielding KL, Churchyard GJ. Association of isoniazid preventive therapy with lower early mortality in individuals on antiretroviral therapy in a workplace programme. AIDS. 2010 Nov;24 Suppl 5(0 5):S5-13. doi: 10.1097/01.aids.0000391010.02774.6f.
PubMed 21079429
Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, Cohn S, Efron A, Chaisson RE, Golub JE. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013 Oct;13(10):852-8. doi: 10.1016/S1473-3099(13)70187-7. Epub 2013 Aug 16.
PubMed 23954450
Golub JE, Pronyk P, Mohapi L, Thsabangu N, Moshabela M, Struthers H, Gray GE, McIntyre JA, Chaisson RE, Martinson NA. Isoniazid preventive therapy, HAART and tuberculosis risk in HIV-infected adults in South Africa: a prospective cohort. AIDS. 2009 Mar 13;23(5):631-6. doi: 10.1097/QAD.0b013e328327964f.
PubMed 19525621
Golub JE, Saraceni V, Cavalcante SC, Pacheco AG, Moulton LH, King BS, Efron A, Moore RD, Chaisson RE, Durovni B. The impact of antiretroviral therapy and isoniazid preventive therapy on tuberculosis incidence in HIV-infected patients in Rio de Janeiro, Brazil. AIDS. 2007 Jul 11;21(11):1441-8. doi: 10.1097/QAD.0b013e328216f441.
PubMed 17589190
Gupta A, Wood R, Kaplan R, Bekker LG, Lawn SD. Tuberculosis incidence rates during 8 years of follow-up of an antiretroviral treatment cohort in South Africa: comparison with rates in the community. PLoS One. 2012;7(3):e34156. doi: 10.1371/journal.pone.0034156. Epub 2012 Mar 30.
PubMed 22479548
Samandari T, Agizew TB, Nyirenda S, Tedla Z, Sibanda T, Shang N, Mosimaneotsile B, Motsamai OI, Bozeman L, Davis MK, Talbot EA, Moeti TL, Moffat HJ, Kilmarx PH, Castro KG, Wells CD. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 May 7;377(9777):1588-98. doi: 10.1016/S0140-6736(11)60204-3. Epub 2011 Apr 12.
PubMed 21492926
Yirdaw KD, Jerene D, Gashu Z, Edginton ME, Kumar AM, Letamo Y, Feleke B, Teklu AM, Zewdu S, Weiss B, Ruff A. Beneficial effect of isoniazid preventive therapy and antiretroviral therapy on the incidence of tuberculosis in people living with HIV in Ethiopia. PLoS One. 2014 Aug 8;9(8):e104557. doi: 10.1371/journal.pone.0104557. eCollection 2014.
PubMed 25105417
INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.
PubMed 26192873
TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
PubMed 26193126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROvide MIner-friendly SErvices for Integrated TB/HIV Care in Lesotho Study (PROMISE Study)
ClinicalTrials.gov ID: NCT03537872
Acronym / sponsor ID: PROMISE / AAAR3789
Conditions: HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, Ministry of Health, Lesotho, National University of Lesotho (NUL)
Study start: 13 Mar 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 25 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Miner-Friendly (MF) Cohort	Experimental	Behavioral: Miner-Friendly (MF) Service Venues TB/HIV Integration StrategiesSubjects 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	Active comparator	Behavioral: Public Sector (PS) Health Facilities TB/HIV Integration StrategiesSubjects 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

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Miner-Friendly (MF) Service Venues TB/HIV Integration StrategiesAlso: MF interventionIn 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)	Behavioural	Miner-Friendly (MF) Cohort
Public Sector (PS) Health Facilities TB/HIV Integration StrategiesAlso: Control Condition (PS)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	Behavioural	Public Sector (PS) Cohort

Primary outcome

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.
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.

9 secondary outcomes

CD4 count at enrollment
Time frame: Up to 3 weeks after 9-month interview
Time to ART initiation
Time frame: Up to 3 weeks after 9-month interview
Time to IPT initiation
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
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
Time frame: 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
Percentage of total prescribed doses of ART ingested, by self-report, averaged across study visits
Time frame: 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
Percentage of total prescribed doses of IPT ingested, by self-report, averaged across study visits
Time frame: Up to 9 months post baseline interview

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
BackgroundLesotho Ministry of Health, ICF International. Lesotho Demographic and Health Survey 2014. Key Indicators Report. Maseru; 2015.
BackgroundGlobal tuberculosis report 2016. Geneva, Switzerland: World Health Organization; 2016.
BackgroundHoward AA, Saito S, Frederix K, Hirsch-Moverman Y, Maama LB, Tau P, et al. Integrating TB/HIV Services for Migrant Miners and Their Families in Lesotho. Conference on Retroviruses and Opportunistic Infections February 22-25, 2016. Boston. Abstract 738.
Background: PubMed 20516372Stuckler D, Basu S, McKee M, Lurie M. Mining and risk of tuberculosis in sub-Saharan Africa. Am J Public Health. 2011 Mar;101(3):524-30. doi: 10.2105/AJPH.2009.175646. Epub 2010 Jun 1.
Background: PubMed 16546541Corbett EL, Marston B, Churchyard GJ, De Cock KM. Tuberculosis in sub-Saharan Africa: opportunities, challenges, and change in the era of antiretroviral treatment. Lancet. 2006 Mar 18;367(9514):926-37. doi: 10.1016/S0140-6736(06)68383-9.
Background: PubMed 20397949Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clin Infect Dis. 2010 May 15;50 Suppl 3:S201-7. doi: 10.1086/651492.
Background: PubMed 21079429Charalambous S, Grant AD, Innes C, Hoffmann CJ, Dowdeswell R, Pienaar J, Fielding KL, Churchyard GJ. Association of isoniazid preventive therapy with lower early mortality in individuals on antiretroviral therapy in a workplace programme. AIDS. 2010 Nov;24 Suppl 5(0 5):S5-13. doi: 10.1097/01.aids.0000391010.02774.6f.
Background: PubMed 23954450Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, Cohn S, Efron A, Chaisson RE, Golub JE. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013 Oct;13(10):852-8. doi: 10.1016/S1473-3099(13)70187-7. Epub 2013 Aug 16.
Background: PubMed 19525621Golub JE, Pronyk P, Mohapi L, Thsabangu N, Moshabela M, Struthers H, Gray GE, McIntyre JA, Chaisson RE, Martinson NA. Isoniazid preventive therapy, HAART and tuberculosis risk in HIV-infected adults in South Africa: a prospective cohort. AIDS. 2009 Mar 13;23(5):631-6. doi: 10.1097/QAD.0b013e328327964f.
Background: PubMed 17589190Golub JE, Saraceni V, Cavalcante SC, Pacheco AG, Moulton LH, King BS, Efron A, Moore RD, Chaisson RE, Durovni B. The impact of antiretroviral therapy and isoniazid preventive therapy on tuberculosis incidence in HIV-infected patients in Rio de Janeiro, Brazil. AIDS. 2007 Jul 11;21(11):1441-8. doi: 10.1097/QAD.0b013e328216f441.
Background: PubMed 22479548Gupta A, Wood R, Kaplan R, Bekker LG, Lawn SD. Tuberculosis incidence rates during 8 years of follow-up of an antiretroviral treatment cohort in South Africa: comparison with rates in the community. PLoS One. 2012;7(3):e34156. doi: 10.1371/journal.pone.0034156. Epub 2012 Mar 30.
Background: PubMed 21492926Samandari T, Agizew TB, Nyirenda S, Tedla Z, Sibanda T, Shang N, Mosimaneotsile B, Motsamai OI, Bozeman L, Davis MK, Talbot EA, Moeti TL, Moffat HJ, Kilmarx PH, Castro KG, Wells CD. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 May 7;377(9777):1588-98. doi: 10.1016/S0140-6736(11)60204-3. Epub 2011 Apr 12.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea A. Howard, MD, MS principal investigator

ICAP at Columbia University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of newly diagnosed HIV-positive participants initiated on ART (ART Initiation) (time frame: Up to 3 weeks after 9-month interview). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537872, which also lists 89 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.