An interventional study of Impart Assisted Partner Notification and Self-Tell Notification in HIV, sponsored by University of Illinois at Chicago. Recruiting at 1 site in Indonesia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Screening
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.
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.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's planned enrollment of 216 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Impart Assisted Partner Notification · Behavioral: Self-Tell Notification
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.
Behavioral: Self-Tell 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.
Also known as: HIV partner notification, Provider-assisted partner notification
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.
HIV Testing
Number of partners who complete HIV testing
Time frame: 6 weeks after randomization
HIV Notification
Number of partners who are notified of possible shared exposure to HIV
Time frame: 6 weeks post-randomization
First HIV Test
Number of partners who are HIV testing for the first time
Time frame: 6 weeks post-randomization
HIV Diagnosis
Number of partners who are HIV diagnosed
Time frame: 6 weeks post-randomization
ART Linkage
Number of HIV-diagnosed partners who are evaluated for treatment by a physician
Time frame: 6 weeks post-randomization
ART Initiation
Number of HIV-diagnosed partners who initiate treatment with antiretroviral therapy (ART)
Time frame: 6 weeks post-randomization
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: We will share data with the research community when papers using the data have been accepted for publication or at the end of the award period, whichever occurs sooner.
Access criteria: Access to de-identified scientific data will not be restricted. Due to the sensitive nature of the topic, identifiable data will be limited to sharing through data use agreements.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's planned 27 months is below that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
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