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

August 11, 2021 updated by: Jan Ostermann, University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HIV counseling and testing (HCT) is a highly cost-effective intervention for increasing serostatus awareness, a point of entry into HIV care and treatment, and an important means of primary and secondary HIV prevention. Public health officials have called for dramatic increases in HIV testing to achieve an HIV-free generation. Yet, testing rates are plateauing and rates of repeat-testing among those with ongoing risk remain low. Thus, there is a need to better understand and address deterrents of HIV testing.

Evaluations of population preferences for testing have typically focused on the acceptability of specific venue-based testing options, such as home-based, provider-initiated, or workplace testing, usually without consideration or offer of other options. Results from these assessments do not probe the potential diversity in testing preferences of target populations; they do not ascertain how individuals value diverse characteristics of testing options; nor can they identify combinations of testing options that could maximize uptake of testing. The investigators posit that systematically designed HIV testing interventions, matched specifically to the heterogeneous preferences of diverse target populations, hold potential to greatly improve uptake of testing.

In this study the investigators will extend the use of the DCE method to design an HIV testing intervention that is matched to the specific preferences of two high-risk populations and to establish, in a pragmatic randomized controlled trial, whether a Preference-Based HIV Counseling and Testing (PB-HCT) intervention increases uptake of HIV testing. In short, the investigators are adapting concepts from health and behavioral economics, marketing, and patient-centered care to apply a groundbreaking, client-focused perspective to the context of HIV testing.

This application will address the following Specific Aims:

Aim 1 will identify which combination of HIV counseling and testing options is expected to maximize uptake of HIV testing in two high-risk populations. We will use formative work and DCE surveys with female barworkers and male Kilimanjaro mountain porters, two high HIV risk populations in Moshi, Tanzania, to quantify the relative importance of characteristics such as home-based vs. facility-based testing, venipuncture vs. finger prick vs. oral swab, individual vs. couples counseling, the availability of services such as health check-ups, and options for HIV serostatus disclosure, for individuals' testing decisions. Latent class analysis of DCE choice data will identify distinct sets of testing preferences within each high-risk population, and identify a combination of testing options that is predicted to maximize uptake of testing.

Aim 2 will evaluate whether an HIV testing offer, matched to the testing preferences of each high-risk population, increases testing uptake relative to a common option. Representative samples of 600 female barworkers and 600 male mountain porters will be randomized into three groups (Groups A, B, and C). Participants will be offered one common option (this option is the same regardless of which group a participant is randomized into) and 3 group-specific testing options. Group A participants will be offered 3 currently available testing options targeted at the distribution of preferences among participants. Group B participants will be offered 3 preference-informed "enhanced" testing options, which include features that may not yet be available in the study area. Group C participants will be offered an equal number of predicted less-preferred options. The primary outcome is uptake of HIV testing.

The findings from this project have significant public health relevance. The proposed study will a) rigorously characterize the HIV testing preferences of two high-risk populations; b) identify feasible HIV testing interventions that are predicted to increase HCT uptake; and c) identify the effect of a preference-informed HIV testing intervention on rates of testing. More generally, this study evaluates the critical link between an intervention that is systematically designed to match a population's preferences and the efficacy of that intervention. If successful, preference assessments among small samples from key populations could be used widely as an implementation research tool to inform the design of diverse HIV prevention, testing, and treatment interventions; preference-informed interventions, in turn, hold potential to broadly increase intervention uptake and efficacy, both internationally and in the United States.

Study Type

Interventional

Enrollment (Actual)

1194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Kilimanjaro Region
      • Moshi, Kilimanjaro Region, Tanzania
        • Kilimanjaro Clinical Research Institute
  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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: SMS Reminder
Participants will receive an SMS reminder to test.
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.
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: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HIV testing - 3 months
Time Frame: 3 months
Percent of participants who test for HIV
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HIV testing - 15 months
Time Frame: 15 months
Percent of participants who test for HIV
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

Duke University
Kilimanjaro Christian Medical Centre, Tanzania

Investigators

  • Principal Investigator: Jan Ostermann, PhD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2018

Primary Completion (ACTUAL)

October 31, 2020

Study Completion (ACTUAL)

October 31, 2020

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH106388 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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