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HIV TestingDCE-IMPACTNCT02714140

Does Preference-based HIV Testing Increase Uptake in High Risk Populations?

A study testing PB-HCT +, PB-HCT - and Economic incentive in people with HIV Testing, run by University of South Carolina at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Testing
What is being tested?
PB-HCT +, PB-HCT - and Economic incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,194 participants
Where
3 sitesin 2 countries
Study dates
3 Jan 2018to 31 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • University of South Carolina

    Columbia, South Carolina, 29208

  • Duke University

    Durham, North Carolina, 27708

Other trials in United States

Tanzania1 site
  • Kilimanjaro Clinical Research Institute

    Moshi, Kilimanjaro

Other trials in Tanzania

About this study

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.

Read the 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.

Conditions
HIV Testing
Being tested
PB-HCT +, PB-HCT -, Economic incentive, PB-HCT ++, SMS Reminder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PB-HCT +Behavioural

    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.

  • PB-HCT -Behavioural

    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

  • Economic incentiveBehavioural

    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.

  • PB-HCT ++Behavioural

    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.

  • SMS ReminderBehavioural

    Participants will receive an SMS reminder to test.

Study groups in NCT02714140
Study groupRoleWhat they receive
Group A: More preferred Existing + CommonExperimentalGroup A participants will be offered the common option and 3 currently available testing options that are targeted at the distribution of preferences among participants.
Receives: Behavioral: PB-HCT +; Behavioral: Economic incentive; Behavioral: SMS Reminder
Group B: More preferred Enhanced + CommonExperimentalGroup 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.
Receives: Behavioral: Economic incentive; Behavioral: PB-HCT ++; Behavioral: SMS Reminder
Group C: Less preferred + CommonActive comparatorGroup 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.
Receives: Behavioral: PB-HCT -; Behavioral: Economic incentive; Behavioral: SMS Reminder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uptake of HIV testing - 3 months

    Percent of participants who test for HIV

    Measured: 3 months

Secondary outcomes (1)
  1. Uptake of HIV testing - 15 months

    Percent of participants who test for HIV

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study start3 Jan 2018
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714140
Sponsor's protocol ID
R01MH106388
Acronym
DCE-IMPACT
Status last verified
Aug 2021
First submitted
16 Mar 2016
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ostermann J, Njau B, Brown DS, Muhlbacher A, Thielman N. Heterogeneous HIV testing preferences in an urban setting in Tanzania: results from a discrete choice experiment. PLoS One. 2014 Mar 18;9(3):e92100. doi: 10.1371/journal.pone.0092100. eCollection 2014.

    PubMed 24643047
  • Njau B, Ostermann J, Brown D, Muhlbacher A, Reddy E, Thielman N. HIV testing preferences in Tanzania: a qualitative exploration of the importance of confidentiality, accessibility, and quality of service. BMC Public Health. 2014 Aug 12;14:838. doi: 10.1186/1471-2458-14-838.

    PubMed 25124140
  • Ostermann J, Njau B, Mtuy T, Brown DS, Muhlbacher A, Thielman N. One size does not fit all: HIV testing preferences differ among high-risk groups in Northern Tanzania. AIDS Care. 2015;27(5):595-603. doi: 10.1080/09540121.2014.998612. Epub 2015 Jan 23.

    PubMed 25616562
  • Ostermann J, Brown DS, Muhlbacher A, Njau B, Thielman N. Would you test for 5000 Shillings? HIV risk and willingness to accept HIV testing in Tanzania. Health Econ Rev. 2015 Dec;5(1):60. doi: 10.1186/s13561-015-0060-8. Epub 2015 Aug 19.

    PubMed 26285777
  • Ostermann J, Njau B, Hobbie A, Mtuy T, Masaki ML, Shayo A, van Zwetselaar M, Masnick M, Flaherty B, Brown DS, Muhlbacher AC, Thielman NM. Using discrete choice experiments to design interventions for heterogeneous preferences: protocol for a pragmatic randomised controlled trial of a preference-informed, heterogeneity-focused, HIV testing offer for high-risk populations. BMJ Open. 2020 Nov 6;10(11):e039313. doi: 10.1136/bmjopen-2020-039313.

    PubMed 33158826
  • Ostermann J, Njau B, Hobbie AM, Mtuy TB, Masnick M, Brown DS, Muhlbacher AC, Thielman NM. Divergent preferences for enhanced HIV testing options among high-risk populations in northern Tanzania: a short report. AIDS Care. 2023 Sep;35(9):1270-1278. doi: 10.1080/09540121.2022.2119471. Epub 2022 Sep 5.

    PubMed 36063533
  • Ostermann J, Njau B, Masaki M, Mtuy T, Itemba D, Hobbie A, Yelverton V, Moore S, Yamanis T, Thielman NM. Feasibility, Acceptability, and Potential Cost-Effectiveness of a Novel Mobile Phone Intervention to Promote Human Immunodeficiency Virus Testing Within Social Networks in Tanzania. Sex Transm Dis. 2022 Nov 1;49(11):778-781. doi: 10.1097/OLQ.0000000000001611. Epub 2022 Jan 29.

    PubMed 35093981

Questions about this trial

What is this clinical trial studying?

A study testing PB-HCT +, PB-HCT - and Economic incentive in people with HIV Testing, run by University of South Carolina at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uptake of HIV testing - 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714140, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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