Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

NCT ID: NCT03718871

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-08-01

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.

Conditions

HIV/AIDS; Health Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Healer HIV testing intervention

We will follow Ugandan National protocols to administer voluntary HIV testing at 9 TH practice locations throughout Mbarara District over a 9 month period.

Group Type: EXPERIMENTAL

HIV testing at traditional healer practices

Intervention Type: BEHAVIORAL

HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care.

Healer control arm

Patients will undergo protcolized usual TH care at 8 practices, which include HIV education and a referral to receive VCT through existing resources. Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HIV testing at traditional healer practices

HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mbarara University of Science and Technology

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Radhika Sundararajan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Mbarara University of Science and Technology

Mbarara, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 34678199 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1803019105

Identifier Type: -

Identifier Source: org_study_id

K23MH111409

Identifier Type: NIH

Identifier Source: secondary_id

View Link