Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

NCT03718871 | Completed Results

• 2 other identifiers: 1803019105K23MH111409
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Health Behaviors

Outcome Measures

Primary Outcomes (1)

• Number of TH Clients Who Received HIV Testing

  Primary study outcome was receipt of an HIV test within 90 days of enrollment. In the control arm, this was assessed via self-report at time of 90-day phone call follow up. For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit. If the HIV test was accepted and delivered, the healer recorded the result of the test.

  within 3 months following study visit

Secondary Outcomes (5)

• Number of New HIV Diagnoses Among TH Clients

  within three months following enrollment.

• Number of Patients With +HIV Test Who Successfully Link to HIV Care

  at three months following enrollment.

• Age in Years of Control Arm Subjects Who Received an HIV Test

  3 months following study enrollment

• Gender of Control Arm Subjects Who Received an HIV Test

  at 3 months following enrollment

• Highest Level of Education for Control Arm Subjects Who Received an HIV Test

  at 3 months following study enrollment

Study Arms (2)

Healer HIV testing intervention

EXPERIMENTAL

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

Behavioral: HIV testing at traditional healer practices

Healer control arm

NO INTERVENTION

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.

Interventions

HIV testing at traditional healer practices 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 HIV testing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Mbarara University of Science and Technology: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (1)

• 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.

  PMID: 34678199 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Health Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Limitations and Caveats

Our goal was to evaluate the effectiveness of delivering HIV testing via a novel implementation strategy. This was not a large-scale cost-effectiveness trial. Future studies are needed to evaluate program cost. Since we excluded healers with the lowest patient volume, results may not be generalizable to these smaller practices.

Results Point of Contact

• Title: Dr. Radhika Sundararajan
• Organization: Weill Cornell Medicine

ras9199@med.cornell.edu

(646) 962-4654

Study Officials

• Radhika Sundararajan, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: October 25, 2018
• Study Start: July 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

UG (1)