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Trial record 21 of 83929 for:    testing

Does Preference-based HIV Testing Increase Uptake in High Risk Populations? (DCE-IMPACT)

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ClinicalTrials.gov Identifier: NCT02714140
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Duke University
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Jan Ostermann, University of South Carolina

Brief Summary:
Despite worldwide efforts to promote HIV Counseling and Testing (HCT), rates of testing remain low. Understanding how high risk groups decide to test and adapting available testing options to their preferences has the potential to broadly improve HCT uptake and cost-effectiveness. This study proposes to use a Discrete Choice Experiment, a survey method increasingly used by health economists for the design of patient-centered health care options, to rigorously quantify HIV testing preferences among two high-risk populations, identify their preferred testing options, and evaluate, in a pragmatic randomized controlled trial (RCT), the effect of a preference-based HIV counseling and testing (PB-HCT) intervention on testing uptake. At a time of heightened focus on health preferences research and patient-centered care, this study evaluates the critical link between preference-based intervention design and efficacy. If the RCT indicates that PB-HCT increases testing rates, the testing options evaluated in this R01 can be offered to high-risk populations in the study area, and the preference elicitation method and tools can be used to inform the design of testing options that better match the preferences of other high-risk populations and in other settings.

Condition or disease Intervention/treatment Phase
HIV Testing Behavioral: PB-HCT + Behavioral: PB-HCT - Behavioral: Economic incentive Behavioral: PB-HCT ++ Behavioral: SMS Reminder Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Does Preference-based HIV Testing Increase Uptake in High Risk Populations?
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group A: More preferred Existing + Common
Group A participants will be offered the common option and 3 currently available testing options that are targeted at the distribution of preferences among participants.
Behavioral: PB-HCT +
Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all EXISTING HIV testing options for each participant and select those 3 PB-HCT options that jointly maximize the share of participants predicted to prefer at least one of the three options over the common option.

Behavioral: Economic incentive
Participants will be re-contacted three months after being offered PB-HCT options. Participants will be reminded of the options, and offered an incentive to present for testing using any of the PB-HCT options or the common option.

Behavioral: SMS Reminder
Participants will receive an SMS reminder to test.

Experimental: Group B: More preferred Enhanced + Common
Group B participants will be offered the common option and 3 preference-informed "enhanced" testing options, which include combinations of features that may not yet be available in the study area.
Behavioral: Economic incentive
Participants will be re-contacted three months after being offered PB-HCT options. Participants will be reminded of the options, and offered an incentive to present for testing using any of the PB-HCT options or the common option.

Behavioral: PB-HCT ++
Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all feasible ENHANCED HIV testing options for each participant and select those 3 PB-HCT options that jointly maximize the share of participants predicted to prefer at least one of the three options over the common option.

Behavioral: SMS Reminder
Participants will receive an SMS reminder to test.

Active Comparator: Group C: Less preferred + Common
Group C participants will be offered the common option and 3 predicted less-preferred options. With the common option being the best option in Group C, this group is effectively a non-PB-HCT comparison group.
Behavioral: PB-HCT -
Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all feasible HIV testing options for each participant and select 3 PB-HCT options that are less preferred than the common option

Behavioral: Economic incentive
Participants will be re-contacted three months after being offered PB-HCT options. Participants will be reminded of the options, and offered an incentive to present for testing using any of the PB-HCT options or the common option.

Behavioral: SMS Reminder
Participants will receive an SMS reminder to test.




Primary Outcome Measures :
  1. Uptake of HIV testing - 3 months [ Time Frame: 3 months ]
    Percent of participants who test for HIV


Secondary Outcome Measures :
  1. Uptake of HIV testing - 15 months [ Time Frame: 15 months ]
    Percent of participants who test for HIV



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Males who work as Kilimanjaro mountain porters, Females who regularly work at a bar, hotel or restaurant establishment and serve alcohol to patrons.
  • Eligible participants will be ages 18+, reside in Moshi, Tanzania and have no plans to leave the study area.

Exclusion Criteria:

  • Participants who are not able to see will be excluded owing to the visual nature of the survey presented to elicit preferences.

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): NCT02714140


Contacts
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Contact: Jan Ostermann, PhD 919-339-1110 jano@mailbox.sc.edu
Contact: Nathan Thielman, MD (919) 668-1721 n.thielman@duke.edu

Locations
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United States, North Carolina
Duke University Active, not recruiting
Durham, North Carolina, United States, 27708
United States, South Carolina
University of South Carolina Active, not recruiting
Columbia, South Carolina, United States, 29208
Tanzania
Kilimanjaro Clinical Research Institute Recruiting
Moshi, Kilimanjaro Region, Tanzania
Contact: Gileard Masenga, MD    +255272750979    edr@kcmc.ac.tz   
Sponsors and Collaborators
University of South Carolina
Duke University
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
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Principal Investigator: Jan Ostermann, PhD University of South Carolina

Publications:
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Responsible Party: Jan Ostermann, Associate Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT02714140     History of Changes
Other Study ID Numbers: R01MH106388 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No