Trial · NCT07895823
Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study
NCT07895823, Phase 4, Not yet recruiting, University of North Carolina, Chapel Hill
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study. Trials, record NCT07895823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07895823
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study
- NCT number
- NCT07895823
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- HIV Infection
- Interventions
- Field-based LA-CAB/RPV
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of preliminarily eligible participants who accept and receive field-based injection (acceptability) | From enrollment to the end of participation at 7 months | |
| Primary | Median acceptability of intervention (AIM) score (acceptability) | Month 3, Month 7 | AIM scores are calculated using the following scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scores are calculated from a version of the following four questions: (1) The intervention meets my approval, (2) The intervention is appealing to me, (3) I like the intervention, and (4) I welcome the intervention. Scores are summed across participant and summaries of these scores are provided, minimum score is 4 and maximum score is 20 which corresponds to perfect acceptability. |
| Primary | Median HIV treatment burden score (acceptability) | Month 0, Month 3, Month 7 | The Treatment burden Questionnaire (TBQ) is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It has been adapted to include 13 items rated on a Likert scale ranging from 0 (not at all difficult) to 5 (extremely difficult) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 13 to 65. Higher scores reflect higher treatment burden. |
| Primary | Percentage of participants who receive all indicated LA-CAB/RPV injections within the allowable 14-day window (feasibility) | From enrollment to the end of participation at 7 months | As extracted from study administration and, where appropriate, clinic records, the date of injections will be determined as falling within or outside the acceptable window period. This outcome will be calculated as the percent of all participants with an indication for receipt of LA-CAB/RPV (that is, has not been excluded from further injections identified after receipt of first injection or failure to achieve appropriate decline in HIV RNA levels or viral suppression prompting transition to alternative agent), who receive all indicated injections within the acceptable 14-day window period, as determined by the date of the prior injection. |
| Secondary | Percentage of participants with HIV RNA <200 copies/mL at 7 months (viral suppression) | Month 7 | Among all participants with HIV RNA available within allowable final study visit window (week 28) (obtained through study procedures or clinical care), percent with HIV RNA \<200 copies/mL. Participants without HIV RNA available within allowable final study visit window (week 28), and for whom \>2 months have elapsed since their last injection at the end of closure of that window will be assumed to have HIV RNA \>200 copies/mL. |
| Secondary | Percentage of participants with HIV RNA <200 copies/mL at their end of study visit (viral suppression) | From enrollment through end of study (month 7) | among all participants based on their final study visit, regardless of retention in study procedures through 7-month follow-up, percent with HIV RNA \<200 at their final study visit. |
| Secondary | Percentage of participants with viremia >200 copies/mL at enrollment who suppress to <200 copies/mL by month 7 (viral suppression) | From enrollment through end of study (month 7) | Among participants who have an HIV RNA \>200 copies/mL on D0, the percent who have at least one HIV RNA \<200 copies/mL during follow-up evaluations through month 7. |
| Secondary | Percentage of participants with a HIV clinic visit within 7 months from enrollment on study (re-engagement) | From enrollment through end of study (month 7) | Among all enrolled persons, what percent attended at least one clinic visit (in-person or virtual) with a non-study affiliated primary HIV provider within 7-month follow-up period. |
| Secondary | Percentage of eligible PWH contacted (recruitment and engagement) | from screening to end of recruitment (~12 months) | Among persons with HIV who are pre-screened as eligible and with at least one contact attempt made by study staff, what percent are contacted (defined as speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), regardless of persons eventual eligibility or screening outcomes. |
| Secondary | Percentage of contacted PWH who are screened for the study (recruitment and engagement) | from screening to end of recruitment (~12 months) | Among persons with HIV who are contacted (defined as having at least one contact made by staff including speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), what percent undergo screening for study eligibility |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34MH139436 | Reaching persons with HIV who are out of care through Expedited access to Long-Acting Injectable antiretroviral therapy -"RELAI" | RUTSTEIN, SARAH E. | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL INSTITUTE OF MENTAL HEALTH | 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07895823
GET https://conductscience.org/api/trials/v1/NCT07895823/registered