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Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

Primary Purpose

HIV/AIDS, Health Behaviors

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
HIV testing at traditional healer practices
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Healer HIV testing intervention

Healer control arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of New HIV Diagnoses Among TH Clients
For intervention arm participants, the healer recorded the result of the point-of-care HIV test for those participants who agreed to test during the study visit. In the control arm, this outcomes was assessed via self-report during the 90-day follow up phone call.
Number of Patients With +HIV Test Who Successfully Link to HIV Care
This outcome was assessed via self-report during the 90-day follow up phone call. For participants newly testing HIV-positive, questions were posed to determine if they had received confirmatory testing, and initiated ART medication.
Age in Years of Control Arm Subjects Who Received an HIV Test
Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Participant age in years at time of study enrollment, and association with primary outcome of receiving an HIV test
Gender of Control Arm Subjects Who Received an HIV Test
Self-reported participant gender and association with primary study outcome of receiving an HIV test
Highest Level of Education for Control Arm Subjects Who Received an HIV Test
Participant self-reported highest level of education, and association with study primary outcome of receiving an HIV test

Full Information

First Posted
April 21, 2018
Last Updated
February 11, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03718871
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Health Behaviors

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healer HIV testing intervention
Arm Type
Experimental
Arm Description
We will follow Ugandan National protocols to administer voluntary HIV testing at 9 TH practice locations throughout Mbarara District over a 9 month period.
Arm Title
Healer control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIV testing at traditional healer practices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of TH Clients Who Received HIV Testing
Description
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.
Time Frame
within 3 months following study visit
Secondary Outcome Measure Information:
Title
Number of New HIV Diagnoses Among TH Clients
Description
For intervention arm participants, the healer recorded the result of the point-of-care HIV test for those participants who agreed to test during the study visit. In the control arm, this outcomes was assessed via self-report during the 90-day follow up phone call.
Time Frame
within three months following enrollment.
Title
Number of Patients With +HIV Test Who Successfully Link to HIV Care
Description
This outcome was assessed via self-report during the 90-day follow up phone call. For participants newly testing HIV-positive, questions were posed to determine if they had received confirmatory testing, and initiated ART medication.
Time Frame
at three months following enrollment.
Title
Age in Years of Control Arm Subjects Who Received an HIV Test
Description
Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment. Participant age in years at time of study enrollment, and association with primary outcome of receiving an HIV test
Time Frame
3 months following study enrollment
Title
Gender of Control Arm Subjects Who Received an HIV Test
Description
Self-reported participant gender and association with primary study outcome of receiving an HIV test
Time Frame
at 3 months following enrollment
Title
Highest Level of Education for Control Arm Subjects Who Received an HIV Test
Description
Participant self-reported highest level of education, and association with study primary outcome of receiving an HIV test
Time Frame
at 3 months following study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radhika Sundararajan, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified IPD may be shared with other researchers with reasonable, written requests, and approval from all researchers involved with this current study.
Citations:
PubMed Identifier
34678199
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.
Results Reference
derived

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Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

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