Confidential Social Network Referrals for HIV Testing
CONSORT
1 other identifier
interventional
600
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started May 2025
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
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
August 1, 2023
July 1, 2023
1.4 years
January 26, 2023
July 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Uptake of HIV testing
The number of referred clients presenting for HIV testing at participating study sites within 30 days of the testing offer, per 100 index clients.
Within 30 days of the time of the testing offer
Study Arms (2)
CONSORT referrals + Card referrals
EXPERIMENTALIntervention arm
Card referrals alone
ACTIVE COMPARATORControl arm
Interventions
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.
Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.
Eligibility Criteria
You may qualify if:
- at least 18 years old
- live, work, or regularly receive care in Moshi, Tanzania
- literate
You may not qualify if:
- under age 18 years
- does not live, work, or regularly receive care in Moshi, Tanzania
- illiterate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Carolinalead
- Duke Universitycollaborator
- Kilimanjaro Christian Medical Centre, Tanzaniacollaborator
Related Publications (2)
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.
PMID: 35093981BACKGROUNDOstermann J, Njau B, van Zwetselaar M, Yamanis T, McClimans L, Mwangi R, Beti M, Hobbie A, Gass SJ, Mtuy T, Thielman N. Mobile Phone-Based Confidential Social Network Referrals for HIV Testing (CONSORT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 30;13:e55068. doi: 10.2196/55068.
PMID: 38814692DERIVED
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 26, 2023
First Posted
August 1, 2023
Study Start
May 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After publication of study findings
- Access Criteria
- Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.
All investigators are committed to managing and distributing original data and results to enable subsequent availability to the scientific community, policy makers, and other stakeholders. Final research data including metadata and descriptors may be made available after publication of study findings through a CONSORT data repository. Researchers may access data by request to the Principal Investigators. Access will be provided subject to Tanzanian and US rules, laws, regulations and policies and consistent with institutional review board approvals and consent documents. If conditions prevent making some data elements available (e.g., third party data), relevant publications and presentations will be provided.