Clinical trial NCT03718871: Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
Official title: Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Health Behaviors
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
name: National Institute of Mental Health (NIMH)
First posted: 2018-10-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a mixed methods study where Aims 1 and 2 have both qualitative and quantitative arms. Aim 3 is an unblinded intervention, with a control arm, to be delivered in cluster-randomized fashion (Sept 2019-June 2020). Healers will be treated as clusters and randomized to either intervention or control arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: HIV antiretroviral therapy has the potential to dramatically decrease HIV transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is the fact that healthcare is largely provided by traditional or spiritual healers rather than biomedical providers, and there are no strategies in place to identify HIV-infected patients among Traditional Healer patients and link them to HIV care. In order to reach the UNAIDS 90-90-90 benchmarks HIV services must reach marginalized populations in endemic regions, such as in southwestern Uganda. Uganda is one of seven sub-Saharan African (SSA) countries accounting for 90% of all new HIV infections in this region6. HIV prevalence is 7.3%, with \~1.5 million people living with HIV/AIDS and 99,000 new infections in 2014. However, only 50% of sexually active Ugandans have ever tested for HIV8. In the project location of southwestern Uganda, like much of SSA, the majority of Ugandans utilize Traditional Healers (TH), but little is known about Traditional Healer practices or rates of HIV testing (or HIV infection) among their clients. Specific aims of this study are to: 1) identify key socio-structural factors that frame HIV testing behaviors among Ugandan adults who utilize Traditional Healers; 2) investigate acceptability of providing point-of-care HIV testing at Traditional Healer practice locations; and 3) develop and pilot a prospective HIV testing intervention among Traditional Healer patients to promote earlier diagnosis. Results will be used to implement subsequent, large-scale cluster-randomized HIV testing intervention at Traditional Healer practice locations. Findings from the proposed study include formative data on populations that utilize Traditional Healers in an HIV-endemic region of Uganda, and pilot testing of an HIV testing intervention at healer practice locations; these results could be applied towards expanding HIV testing in other low-resource, endemic settings.

Detailed description: This study has three specific aims:

Specific Aim 1: Identify key socio-structural factors that frame HIV testing behaviors among clients of Ugandan TH, using an exploratory sequential, mixed-methods study design. First, qualitative interviews with 25-35 purposely-sampled TH clients will characterize the care-seeking trajectory, HIV testing behaviors and related stigma, healthcare costs, and HIV risks and exposures. Based on these results, a survey will be designed and administered to 300 Ugandan adults who utilize TH in Mbarara District. This cross-sectional study will identify 1) rates of HIV testing among TH clients and 2) variables that independently predict HIV testing within the prior 12 months. These data will inform a model of HIV testing behavior among TH clients based on the Andersen Model of Healthcare Utilization, and generate hypotheses to be tested in Specific Aim 2.

Specific Aim 2: Characterize acceptability of receiving point-of-care (POC) HIV testing at TH locations, using an exploratory sequential, mixed-methods approach. Qualitative interviews with 15-25 purposely sampled TH and 15-25 purposely-sampled TH clients will explore attitudes and experiences with biomedicine, feasibility and acceptability of delivering POC HIV testing at TH locations, and investigate relevant themes emerging from Aim 1. Based on qualitative results, a survey will be developed and administered to 175 TH in Mbarara District. This cross-sectional study will characterize TH practices relevant to HIV testing, and identify characteristics of healers who favorably view the proposed intervention (Specific Aim 3). These data will be integrated with results from SA1 to develop an intervention that will overcome socio-structural barriers to HIV testing.

Specific Aim 3: Develop and pilot an HIV testing intervention among TH clients using a cluster randomized study design. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 9 TH practice locations, to be compared with a control group receiving usual TH care at 8 practices. This pilot will offer HIV testing at TH practice sites to 250 TH clients at the intervention arm sites, and offer protocoled usual care to 250 clients at control arm sites. Primary outcome for this study will be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new HIV diagnoses among TH clients, and ii) number of patients with +HIV POC test who successfully link to HIV care in 3 months.

Eligibility criteria: Inclusion Criteria:

* 18 year of age or older
* able to provide informed consent
* not known to be HIV infected
* willing to be contacted at 3 months following enrollment
* willing to complete an exit survey after 3 months

Exclusion Criteria:

* being under the age of 18 years
* incapable of giving informed consent
* previously being diagnosed with HIV
* being unwilling to receive HIV test results
* unwilling to participate in the testing intervention

Primary outcomes:
measure: Number of TH Clients Who Received HIV Testing
timeFrame: within 3 months following study visit
Secondary outcomes:
measure: Number of New HIV Diagnoses Among TH Clients
timeFrame: within three months following enrollment.
measure: Number of Patients With +HIV Test Who Successfully Link to HIV Care
timeFrame: at three months following enrollment.
measure: Age in Years of Control Arm Subjects Who Received an HIV Test
timeFrame: 3 months following study enrollment
measure: Gender of Control Arm Subjects Who Received an HIV Test
timeFrame: at 3 months following enrollment
measure: Highest Level of Education for Control Arm Subjects Who Received an HIV Test
timeFrame: at 3 months following study enrollment
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Weill Medical College of Cornell University
name: Radhika Sundararajan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundararajan R, Ponticiello M, Lee MH, Strathdee SA, Muyindike W, Nansera D, King R, Fitzgerald D, Mwanga-Amumpaire J. Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial. Lancet Glob Health. 2021 Nov;9(11):e1579-e1588. doi: 10.1016/S2214-109X(21)00366-1.