Confidential Social Network Referrals for HIV Testing (CONSORT)

July 25, 2023 updated by: Jan Ostermann, University of South Carolina

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

No additional detail available

Study Type

Interventional

Enrollment (Estimated)

600

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HIV testing
Time Frame: 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.
Within 30 days of the time of the testing offer

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
  • Principal Investigator: Nathan Thielman, MD, Duke University
  • Principal Investigator: Bernard Njau, PhD, Kilimanjaro Christian Medical Centre, Tanzania

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00120208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of study findings

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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