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

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ClinicalTrials.gov Identifier: NCT03537872
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Ministry of Health, Lesotho
National University of Lesotho (NUL)
Information provided by (Responsible Party):
Andrea Howard, 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.


Condition or disease Intervention/treatment Phase
HIV Behavioral: Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies Behavioral: Public Sector (PS) Health Facilities TB/HIV Integration Strategies Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 641 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PROvide MIner-friendly SErvices for Integrated TB/HIV Care in Lesotho Study (PROMISE Study)
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : November 13, 2019
Estimated Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Control Condition (PS)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. CD4 count at enrollment [ Time Frame: Up to 3 weeks after 9-month interview ]
    CD4 count at enrollment in care, collected from medical records.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537872


Contacts
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Contact: Koen Frederix, MBBS, MPH +266-5887-0951 frederixk@icap.org.ls
Contact: Andrea A. Howard, MD, MS aah2138@cumc.columbia.edu

Locations
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Lesotho
Maputsoe Filter Clinic Recruiting
Leribe, Lesotho
Contact: Palesa Makatise    +266-58028657    makatisep@icap.org.ls   
TEBA Leribe Recruiting
Leribe, Lesotho
Contact: Palesa Makatise    +266-58028657    makatisep@icap.org.ls   
TEBA Mafeteng Recruiting
Mafeteng, Lesotho
Contact: Palesa Makatise    +266-58028657    makatisep@icap.org.ls   
Loretto Health Center Recruiting
Maseru, Lesotho
Contact: Palesa Makatise    +266-58028657    makatisep@icap.org.ls   
TEBA Maseru Recruiting
Maseru, Lesotho
Contact: Palesa Makatise    +266-58028657    makatisep@icap.org.ls   
Sponsors and Collaborators
Columbia University
Centers for Disease Control and Prevention
Ministry of Health, Lesotho
National University of Lesotho (NUL)
Investigators
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Principal Investigator: Andrea A. Howard, MD, MS ICAP at Columbia University

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.
TEMPRANO ANRS 12136 Study Group, Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpé JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouamé A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibé B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouamé E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundzé S, Hawerlander D, Ani A, Dembélé F, Koné F, Guéhi C, Kanga C, Koule S, Séri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoué 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-Semdé C, Kouame A, Massumbuko JM, Chêne G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholié 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.
World Health Organization. Guidelines for intensifed tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Geneva; WHO 2010.
World Health Organization. Policy brief: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: What's new. November 2015. Geneva; WHO 2015.
Lesotho Ministry of Health. Global AIDS response progress report 2015: Lesotho country report. Reporting period January-December 2014. Maseru; 2015.
World Health Organization. Global tuberculosis control 2015. Geneva; WHO; 2015. http://www.who.int/tb/publications/global_report/gtbr15_main_text.pdf. Accessed Jan 20, 2016.
Joint United Nations Programme on HIV/AIDS (UNAIDS). 90-90-90 An ambitious treatment target to help end the AIDS epidemic. http://www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf; Accessed March 22, 2016.
PEPFAR Scientific Advisory Board (SAB). Recommendations Regarding Provision of ART for all Persons Living with HIV ("Test and START"). http://www.pepfar.gov/documents/organization/250048.pdf. Accessed March 21, 2016.
Joint United States Programme on HIV/AIDS (UNAIDS). The GAP Report. Geneva; 2014. http://www.unaids.org/sites/default/files/media_asset/UNAIDS_Gap_report_en.pdf. Accessed Jul 18, 2015.
Corno L, de Walque D. Mines, migration and HIV/AIDS in southern Africa. J of African Economies 2012;21(3):465-498.
International Organization for Migration. Country assessment on HIV prevention needs of migrants and mobile populations: Lesotho. Pretoria; 2010.
Lesotho National TB Programme. Maseru; 2013.
South African Development Community. Declaration on Tuberculosis in the Mining Sector. Maputo; 2012.
Lesotho Ministry of Health. A situation analysis of miners and ex-miners affected and infected by tuberculosis: Lesotho. Maseru; 2012.
Clinton Health Access Initiative. Health Findings and Recommendations: Domestic and Cross-Border Miners in Lesotho. Maseru; 2015.
Diero L, Carter EJ, Silka A, Kimaiyo S, Gardner A, Yiannoutsos C, et al. The experience and outcomes of isoniazid preventive therapy in an HIV treatment program in Western Kenya. XVII International AIDS Conference 2008. Mexico City. Abstract MOAB0306; 2008.
Shanaube K, Chaila JM, Floyd S, Schaap A, Griffith S, Hayes R, et al. Uptake of HIV Testing in the HPTN 071 (PopART) Trial in Zambia. Conference on Retroviruses and Opportunistic Infections February 22-25, 2016. Boston. Abstract 981.
Emenyonu N MW, Habyarimana J, Pops-Eleches C, Thirumurthy H, Ragland K, Bangsberg DR. Cash transfers to cover clinic transportation costs improve retention in care in a HIV treatment program in rural Uganda. 17th Conference on Retroviruses and Opportunistic Infections 16-19 February 2010. San Francisco. Abstract 831.
El Sadr W, Branson B, Hall HI, Beauchamp G, Donnell D, Torian L, et al. Effect of financial incentives on linkage to care and viral suppression: HPTN 065 (TLC-Plus) Study. Conference on Retroviruses and Opportunistic Infections 23-26 February 2015. Seattle. Abstract 29.
South African Development Community. Policy framework for population mobillity and communicable diseases in the SADC region. Gaborone; 2009.
Group GGATSC. Tobacco Questions for Surveys: A Subset of Key Questions from the Global Adult Tobacco Survey (GATS), 2nd Edition. Atlanta, GA: Centers for Disease Control and Prevention; 2011.
Brock DM, Sarason IG, Sarason BR, Pierce GR. Simultaneous assessment of perceived global and relationship-specific support. Journal of Social and Personal Relationships 1996;13:143-152.
WHO Multi-Country Study on Women's Health and Domestic Violence: core questionnaire and WHO instrument, version 9. Geneva, Switzerland: World Health Organization; 2000.
IsoScreen. Oxfordshire, UK: GFC Diagnostic Ltd.
Patton MW. Developing a time motion study for a lean healthcare environment: University of Kentucky; 2011.
Corbin J, Strauss A. Grounded theory research: Procedures, canons, and evaluative criteria. Qualitative Sociology 1990;13:3-21.
Pathways to Engagement in HIV-Care for Newly Diagnosed South Africans, R01-MH83561, 2009-2014, Susie Hoffman DrPH, PI.

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Responsible Party: Andrea Howard, Associate Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT03537872     History of Changes
Other Study ID Numbers: AAAR3789
U01GH002115 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No