HIVCONSORTNCT05967208
Confidential Social Network Referrals for HIV Testing
A study testing CONSORT referrals and Card referrals in people with HIV, run by University of South Carolina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- CONSORT referrals and Card referrals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- live, work, or regularly receive care in Moshi, Tanzania
- literate
Who cannot join
- under age 18 years
- does not live, work, or regularly receive care in Moshi, Tanzania
- illiterate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
No additional detail available
- Conditions
- HIV
- Being tested
- CONSORT referrals, Card referrals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONSORT referralsBehavioural
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 referralsBehavioural
Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.
| Study group | Role | What they receive |
|---|---|---|
| CONSORT referrals + Card referrals | Experimental | Intervention arm Receives: Behavioral: CONSORT referrals; Behavioral: Card referrals |
| Card referrals alone | Active comparator | Control arm Receives: Behavioral: Card referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of the time of the testing offer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Principal investigator, Jan Ostermann, University of South Carolina
- Investigators
- Jan Ostermann, PhD, Principal investigator, University of South CarolinaNathan Thielman, MD, Principal investigator, Duke UniversityBernard Njau, PhD, Principal investigator, Kilimanjaro Christian Medical Centre, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967208
- Sponsor's protocol ID
- Pro00120208
- Acronym
- CONSORT
- Status last verified
- Jul 2023
- First submitted
- 26 Jan 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35093981Ostermann 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.
PubMed 38814692
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confidential Social Network Referrals for HIV Testing
- ClinicalTrials.gov ID
- NCT05967208
- Acronym / sponsor ID
- CONSORT / Pro00120208
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Duke University, Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
No additional detail available
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONSORT referrals + Card referrals | Experimental | Behavioral: CONSORT referrals, Behavioral: Card referralsIntervention arm |
| Card referrals alone | Active comparator | Behavioral: Card referralsControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old
- live, work, or regularly receive care in Moshi, Tanzania
- literate
Key exclusion criteria (3 listed)
- under age 18 years
- does not live, work, or regularly receive care in Moshi, Tanzania
- illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONSORT referralsParticipants 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. | Behavioural | CONSORT referrals + Card referrals |
| Card referralsParticipants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts. | Behavioural | CONSORT referrals + Card referrals, Card referrals alone |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 35093981Ostermann 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.
- Derived from this study: PubMed 38814692Ostermann 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Ostermann, PhD principal investigator
University of South Carolina
Nathan Thielman, MD principal investigator
Duke University
Bernard Njau, PhD principal investigator
Kilimanjaro Christian Medical Centre, Tanzania
Questions about this trial
What is this clinical trial studying?
A study testing CONSORT referrals and Card referrals in people with HIV, run by University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Ostermann, PhD (+1-803-777-8747, jano@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HIV testing (time frame: Within 30 days of the time of the testing offer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.