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

Principal Investigator(s): 

Co-Investigator(s):

Joanne E. Mantell, PhD

Yael Hirsch-Moverman, PhD, MPH

Suzue Saito, MPhil, MIA, MA

Koen Frederix, MBBS, MPH

L.B. Maama, MD

Regina Mpemi, MS

Funding Agency:

President's Emergency Plan for AIDS Relief (PEPFAR)

Centers for Disease Control and Prevention (CDC) 

Collaborating Institution: 

Centers for Disease Control and Prevention (CDC)

Lesotho Ministry of Health

National University of Lesotho 

Study Location:

Lesotho

Description:

Lesotho has one of the world’s most severe HIV and tuberculosis (TB) epidemics and an economy dependent upon labor migration to South African mines. Thus, it is an ideal setting to study the effectiveness of TB/HIV integration strategies. HIV prevalence in Lesotho is 24.6% and the TB incidence rate is 788 per 100,000, both of which are the world’s second highest. Seventy-two percent of TB patients are HIV-positive. Basotho migrant miners who travel between their homes in Lesotho and work in South African mines and their families are among those with elevated risk of HIV and TB. The TB incidence rate in South African miners is estimated at 3,000-7,000 per 100,000 per year, several-fold higher than that in the populations from which they originate. Testing, linkage, and retention of miners and their families along the TB/HIV care continuum are suboptimal, and TB treatment outcomes are also poor compared with those of the general population. Implementation science research can help to determine an effective strategy for improving early detection of HIV and early initiation of antiretroviral therapy (ART) and isoniazid preventive therapy (IPT) among migrant miners and their families.

The PROvide MIner-friendly SErvices for Integrated TB/HIV Care (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). We will use a prospective cohort study design 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 (MF), compared to public sector health facilities (PS), which will deliver usual integrated care for management of TB and HIV. All participants will be assessed at the time of HIV testing (baseline), and at months 3, 6, and 9. We will measure two primary outcomes: (1) ART initiation; and (2) IPT initiation. Secondary outcomes include: (1) CD4 count at enrollment; (2) time to ART initiation; (3) time to IPT initiation; (4) 6- and 9-month ART retention; 5) 6-month viral load (VL) suppression; (6) IPT completion; (7) ART adherence and (8) IPT adherence. Additionally, we will assess feasibility of the MF intervention strategy by measuring HIV testing yield, linkage to care, time spent accessing ART and IPT services, and costs associated with delivery of the MF intervention. We will also assess acceptability of the MF intervention strategy by exploring patients' and healthcare providers' perceived barriers, facilitators and preferences to understand how they impact uptake and delivery of the MF intervention. Furthermore, this study will assess safety and tolerability of concurrent ART and IPT among PLHIV.