HIVNCT07103928
Prison-Based HIV Partner Notification
A study testing Impart Assisted Partner Notification and Self-Tell Notification in people with HIV, run by University of Illinois at Chicago at 1 site in Indonesia.
Trial summary
Assisted partner notification (APN) is a voluntary and confidential process that utilizes specially-trained health workers to encourage and assist people diagnosed with HIV to inform their sex and drug use partners about possible shared exposure to HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Impart Assisted Partner Notification and Self-Tell Notification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Sep 2026to Dec 2028
- Phase
- Interventional
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-diagnosed
- Sexually active (penile-vaginal or penile-anal) and/or sharing injection equipment during the year before incarceration
Who cannot join
- Incarcerated more than 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Fakultas Ilmu Keperawatan, Universitas Indonesia
Depok, West Java, 16424
Agung Waluyo, PhD, +62-21-7865105, agungwss@ui.ac.id
Tutik Sri Hariyati, PhD, tutik@ui.ac.id
About this study
Assisted partner notification (APN) is a voluntary and confidential process that utilizes specially-trained health workers to encourage and assist people diagnosed with HIV to inform their sex and drug use partners about possible shared exposure to HIV. With APN, partners who have come in contact with HIV are notified about exposure and given information to protect themselves from contracting HIV in the future or to begin treatment, if needed.
This study compares two types of HIV partner notification. Incarcerated men with HIV will be recruited as "index participants". Participants in both groups will be encouraged to notify sex and needle-sharing partners with whom they may have shared an HIV exposure before incarceration. All participants have the option to self-notify partners during a prison visitation or telephone call. In addition, participants randomized to an APN Choice group also can opt for anonymous notification by specially-trained APN notifiers that includes contact tracing if needed. As outcomes, we will compare the number of partners in each condition who are notified, HIV tested, diagnosed, and linked to HIV treatment. The study will show if prison-based APN is successful in reaching partners for HIV testing.
Read the detailed description
This study will evaluate the effectiveness of Impart, an assisted partner notification (APN) intervention that was developed to increase HIV testing and referral into treatment among the sex and drug use partners of incarcerated people with HIV. Incarcerated people with HIV are assigned randomly to one of two groups. Participants assigned to the Impart Choice condition may choose to inform partners themselves by telephone or in person or they may ask specially-trained nurses and outreach workers to confidentially notify partners and to offer partners HIV testing. Meanwhile, participants assigned to the Standard of Care Self-Tell Notification Only condition will be encouraged to tell their partner(s) themselves, either by phone or in person during a prison visitation. As outcomes, we will compare after six weeks the number of partners in each condition who are notified, HIV tested, diagnosed, and linked to confirmatory HIV testing and treatment After 6 weeks, we will offer outreach-assisted partner notification to any participant who was randomized to or initially chose to notify their partners themselves. Results from the study will provide evidence as to the use of prison-based APN in making partner notification desirable and acceptable to people in prison while also reducing barriers to partner notification and HIV testing for their partners in the community.
- Conditions
- HIV
- Being tested
- Impart Assisted Partner Notification, Self-Tell Notification
- Keywords
- HIV, partner notification, contact tracing, sexually transmitted infections, prisons, Injection drug use
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impart Assisted Partner NotificationBehavioural
Also called HIV partner notification, Provider-assisted partner notification
Participants randomized to the Impart arm may choose per partner either a) sell-tell notification or b) having an Impart-trained APN notifier team locate, notify, and offer HIV testing to their partners without revealing the identity of who had named them. Impart notifiers initially contact named partners by telephone and identify themselves as health service providers with important information about the partner's health that needs to be shared in person. Partners who agree to meet are asked to choose a location. Notification by telephone is only delivered as a last resort when circumstances prevent in-person notification or a partner insists on learning the reason for the telephone call. Once contact is made at a private location, partners will be advised of their possible shared exposure to HIV. APN notifiers never reveal participant names or identifying information during this meeting. All notified partners are offered immediate HIV testing and treatment referral, if HIV-positive.
Self-Tell NotificationBehavioural
Participants who wish to self-notify one or more partners are coached to do so either in person or by telephone. APN counselors confirm the names of partners for whom participants provide contact information before giving the phone to the participant to explain the reason for the call: "I want to speak with you because I was diagnosed with HIV and I believe we shared an exposure." Alternately, participants who wish to notify partners in person are coached to inform partners that they have a serious health matter that they wish to discuss, and ask the partner to visit them in jail/prison. Either way, the APN counselor is present to record the names of partners whom participants self-notify, and offers to speak with the partner immediately afterwards to answer their questions about HIV and to provide information about HIV testing and contact information should the partner wish to contact an HIV provider on their own to learn more about HIV testing or to schedule an HIV test.
| Study group | Role | What they receive |
|---|---|---|
| Impart Choice of APN or Self-Tell Per Partner | Experimental | Participants are assisted to identify partners whom they wish to notify and coached in how to tell their at-risk partners by the end of 6 weeks. Participants may choose per partner between sell-tell notification or having an Impart HIV-trained nurse and community outreach healthcare provider work as a team to locate, notify, and offer HIV testing to their partners. Receives: Behavioral: Impart Assisted Partner Notification; Behavioral: Self-Tell Notification |
| Self-Tell Notification Only Standard of Care Condition | Active comparator | Participants are assisted to identify partners whom they wish to notify and coached in how to tell their at-risk partners by the end of 6 weeks. Participants may choose to tell their partner(s) by telephone, mail, or in-person during visitation at the jail/prison facility. They also may elect to have an Impart counselor present during in-person telling or by telephone to answer any clinical questions that the partner might have. Receives: Behavioral: Self-Tell Notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing
Number of partners who complete HIV testing
Measured: 6 weeks after randomization
Secondary outcomes (5)
HIV Notification
Number of partners who are notified of possible shared exposure to HIV
Measured: 6 weeks post-randomization
First HIV Test
Number of partners who are HIV testing for the first time
Measured: 6 weeks post-randomization
HIV Diagnosis
Number of partners who are HIV diagnosed
Measured: 6 weeks post-randomization
ART Linkage
Number of HIV-diagnosed partners who are evaluated for treatment by a physician
Measured: 6 weeks post-randomization
ART Initiation
Number of HIV-diagnosed partners who initiate treatment with antiretroviral therapy (ART)
Measured: 6 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start4 Sep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Agung Waluyo, PhD, Principal investigator, Universitas IndonesiaGabriel Culbert, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103928
- Sponsor's protocol ID
- 2024-0926
- Other IDs
- R01MH138246
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected for this study will follow the NIH Policy for Data Management and Sharing (NOT-OD-21-013) and NIMH's extensions that apply to HIV-related applications that involve human subject research funded by NIMH. Raw and analyzed data from this study will be deposited into the NIMH Data Archive (NDA). Other data outputs also will be housed in the University of Illinois Chicago institutional repository, INDIGO, which is able to store non-sensitive information.
Publications
Culbert GJ, Levy JA, Steffen AD, Waluyo A, Earnshaw VA, Rahadi A. Impart: findings from a prison-based model of HIV assisted partner notification in Indonesia. J Int AIDS Soc. 2023 Jun;26(6):e26132. doi: 10.1002/jia2.26132.
PubMed 37339342Culbert GJ, Waluyo A, Levy JA, Steffen AD, Earnshaw VA, Rahadi A. Prison-based HIV partner notification in Indonesia: rationale and design of a hybrid type 1 effectiveness-implementation study. BMC Public Health. 2026 Mar 16;26(1):1321. doi: 10.1186/s12889-026-26950-z.
PubMed 41840552