Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718871
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
Mbarara University of Science and Technology
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Health Behaviors Behavioral: HIV testing at traditional healer practices Not Applicable

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. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 10 TH practice locations, to be compared with a control group receiving usual TH care. This pilot will offer HIV testing at TH practice sites to 250 TH clients. 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, ii) socio-demographic factors that predict HIV testing, and iii) percentage of patients with +HIV POC test who successfully link to HIV care in 3 months.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 (Sept 2019-June 2020).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Healer HIV testing intervention
We will follow Ugandan National protocols to administer voluntary HIV testing at 5 TH practice locations throughout Mbarara District over a 9 month period.
Behavioral: HIV testing at traditional healer practices
HIV 1/2 antigen-antibody POC test (Alere Determine©) 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 Western Blot confirmation, and linkage to care.

No Intervention: Healer control arm
Patients will undergo usual TH care. After the session, the TH will inform study staff if the client was referred for VCT. Study staff will contact the client once per month, for 3 months, to assess for VCT since enrollment in the study.



Primary Outcome Measures :
  1. Rate of HIV testing among TH clients [ Time Frame: within 3 months following visit ]

Secondary Outcome Measures :
  1. new HIV diagnoses among TH clients [ Time Frame: within 3 months ]
  2. patients with +HIV test who successfully link to HIV care [ Time Frame: within 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 year of age or older
  • able to provide informed consent
  • not known to be HIV infected
  • willing to be contacted for monthly follow up for 3 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718871


Contacts
Layout table for location contacts
Contact: Radhika Sundararajan, MD, PhD 646-962-4654 ras9199@med.cornell.edu
Contact: Juliet Mwanga-Amumpaire, MD +256 793328748 jmwanga@gmail.com

Locations
Layout table for location information
Uganda
Mbarara University of Science and Technology Recruiting
Mbarara, Uganda
Contact: Juliet Mwanga-Amumpaire, MD    (+256) 772 721 751      
Contact: Donny Ndazima, MS         
Sponsors and Collaborators
Weill Medical College of Cornell University
Mbarara University of Science and Technology
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Radhika Sundararajan, MD, PhD Weill Medical College of Cornell University

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03718871     History of Changes
Other Study ID Numbers: 1803019105
K23MH111409 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No