NCT02714140

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2.8 years

First QC Date

March 16, 2016

Last Update Submit

August 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Uptake of HIV testing - 3 months

    Percent of participants who test for HIV

    3 months

Secondary Outcomes (1)

  • Uptake of HIV testing - 15 months

    15 months

Study Arms (3)

Group A: More preferred Existing + Common

EXPERIMENTAL

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 +Behavioral: Economic incentiveBehavioral: SMS Reminder

Group B: More preferred Enhanced + Common

EXPERIMENTAL

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 incentiveBehavioral: PB-HCT ++Behavioral: SMS Reminder

Group C: Less preferred + Common

ACTIVE COMPARATOR

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 -Behavioral: Economic incentiveBehavioral: SMS Reminder

Interventions

PB-HCT ++BEHAVIORAL

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.

Group B: More preferred Enhanced + Common

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.

Group A: More preferred Existing + CommonGroup B: More preferred Enhanced + CommonGroup C: Less preferred + Common
SMS ReminderBEHAVIORAL

Participants will receive an SMS reminder to test.

Group A: More preferred Existing + CommonGroup B: More preferred Enhanced + CommonGroup C: Less preferred + Common

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke University

Durham, North Carolina, 27708, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Kilimanjaro Clinical Research Institute

Moshi, Kilimanjaro, Tanzania

Location

Related Publications (7)

  • 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.

    PMID: 24643047BACKGROUND
  • 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.

    PMID: 25124140BACKGROUND
  • 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.

    PMID: 25616562BACKGROUND
  • 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.

    PMID: 26285777BACKGROUND
  • 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.

    PMID: 33158826BACKGROUND
  • 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.

  • 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.

Study Officials

  • Jan Ostermann, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 21, 2016

Study Start

January 3, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations