Confidential Social Network Referrals for HIV Testing

NCT ID: NCT05967208

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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No additional detail available

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CONSORT referrals + Card referrals

Intervention arm

Group Type EXPERIMENTAL

CONSORT referrals

Intervention Type BEHAVIORAL

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.

Card referrals

Intervention Type BEHAVIORAL

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

Card referrals alone

Control arm

Group Type ACTIVE_COMPARATOR

Card referrals

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Card referrals

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Kilimanjaro Christian Medical Centre, Tanzania

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Jan Ostermann

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Ostermann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Nathan Thielman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Bernard Njau, PhD

Role: PRINCIPAL_INVESTIGATOR

Kilimanjaro Christian Medical Centre, Tanzania

Central Contacts

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Jan Ostermann, PhD

Role: CONTACT

+1-803-777-8747

References

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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.

Reference Type BACKGROUND
PMID: 35093981 (View on PubMed)

Ostermann 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.

Reference Type DERIVED
PMID: 38814692 (View on PubMed)

Other Identifiers

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Pro00120208

Identifier Type: -

Identifier Source: org_study_id

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