Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India

Sunil S Solomon, Gregory M Lucas, David D Celentano, Allison M McFall, Elizabeth Ogburn, Lawrence H Moulton, Aylur K Srikrishnan, M Suresh Kumar, Santhanam Anand, Suniti Solomon, Shruti H Mehta, Sunil S Solomon, Gregory M Lucas, David D Celentano, Allison M McFall, Elizabeth Ogburn, Lawrence H Moulton, Aylur K Srikrishnan, M Suresh Kumar, Santhanam Anand, Suniti Solomon, Shruti H Mehta

Abstract

Background: Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings.

Methods/design: This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys.

Discussion: For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations.

Trial registration: ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012.

Keywords: HIV/ADS; India; Men who have sex with men; People who inject drugs.

Figures

Fig. 1
Fig. 1
Study Design. Abbreviations: MSM, Men who have sex with men; PWID, People who inject drugs; RDS, Respondent-driven sampling; ICC, Integrated care centers
Fig. 2
Fig. 2
Study Sites. Panel a. MSM sites represent cities with established HIV epidemics among MSM (Chennai, Hyderabad, Bengaluru), smaller cities in high HIV prevalence states (Coimbature, Madurai, Vishakapatnam, Vijaywada, Mangalore, Belgaum) and cities with anecdotal reports of HIV among MSM but no published reports (New Delhi, Bhopal, Lucknow). Panel b. PWID sites represent cities with established drug use epidemics (Aizawl, Churchandpur, Dimapur, Gangtok, Imphal, Lunglei, Moreh), large cities (New Delhi, Mumbai) cities with documented emerging drug use epidemics (Amritsar, Chandigarh, Ludhiana) and cities with anecdotal evidence of emerging drug use epidemics (Bilaspur, Bhubaneswar, Kanpur). Note New Delhi has two control sites (one for the MSM stratum and one for the PWID stratum)

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