CONSORT: Confidential Social Network Referrals for HIV Testing

Sponsor

University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05967208

Collaborator

Duke University (Other), Kilimanjaro Christian Medical Centre, Tanzania (Other)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential SMS-based social network referrals for HIV testing as a means of reaching high-risk individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5 specific aims:

Aim 1 will conduct qualitative, formative work to identify desirable provider- and client-side characteristics of a confidential SMS-based HIV testing referral system.

Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality.

Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's acceptability, performance, and potential efficacy.

Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled trial.

Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options.

If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing efforts.

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: CONSORT referrals Behavioral: Card referrals	N/A

Detailed Description

No additional detail available

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Confidential Social Network Referrals for HIV Testing

Anticipated Study Start Date :

May 1, 2025

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CONSORT referrals + Card referrals Intervention arm	Behavioral: CONSORT referrals Participants will be offered SMS-based confidential social network referrals for HIV testing ("CONSORT referrals") to extend to any of their social and sexual network contacts. Behavioral: Card referrals Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.
Active Comparator: Card referrals alone Control arm	Behavioral: Card referrals Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.

Arm

Intervention/Treatment

Experimental: CONSORT referrals + Card referrals

Intervention arm

Behavioral: CONSORT referrals

Participants will be offered SMS-based confidential social network referrals for HIV testing ("CONSORT referrals") to extend to any of their social and sexual network contacts.

Behavioral: Card referrals

Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.

Active Comparator: Card referrals alone

Control arm

Behavioral: Card referrals

Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.

Outcome Measures

Primary Outcome Measures

Uptake of HIV testing [Within 30 days of the time of the testing offer]
The number of referred clients presenting for HIV testing at participating study sites within 30 days of the testing offer, per 100 index clients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

at least 18 years old
live, work, or regularly receive care in Moshi, Tanzania
literate

Exclusion criteria:

under age 18 years
does not live, work, or regularly receive care in Moshi, Tanzania
illiterate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of South Carolina
Duke University
Kilimanjaro Christian Medical Centre, Tanzania

Investigators

Principal Investigator: Jan Ostermann, PhD, University of South Carolina
Principal Investigator: Nathan Thielman, MD, Duke University
Principal Investigator: Bernard Njau, PhD, Kilimanjaro Christian Medical Centre, Tanzania

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Jan Ostermann, Associate Professor, University of South Carolina

ClinicalTrials.gov Identifier:

NCT05967208

Other Study ID Numbers:

Pro00120208

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 1, 2023