The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
NCT Number: NCT06554223
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Human Immunodeficiency Virus
Interventions: BEHAVIORAL: SUSTAIN-DSD|OTHER: Enhanced (guideline-driven) Standard of Care (E-SoC)
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 310
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-19
Completion Date: 2028-12-31

Summary:
The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are:

* Does the SUSTAIN-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression?
* Does the SUSTAIN-DSD intervention help retain people in care at clinics?
* Does SUSTAIN-DSD intervention help reduce treatment interruptions?

Participants will:

* for 24 months, either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where they will pick up 6-months of ART medication and have the option to use peer support group sessions and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions)
* Visit the adherence club to get their blood drawn for viral load tests at 6 months, 12 months, and every 12 months (for SUSTAIN-DSD participants only)
* Visit the clinic to get their blood drawn for viral load tests repeated 3 months after restart of ART medication, then at 12 months and annually there-after, if they are virally suppressed (enhanced standard of care participants only)
* Participate in interviews to discuss their experience with the SUSTAIN-DSD intervention

Primary Outcome Measures: Viral suppression (Viral load <50 c/ml), Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment., 24 months post-enrollment
Secondary Outcome Measures: Viral suppression (Viral load <50 c/ml) at 12 months, Viral suppression (Viral load \<50 c/ml) will be measured at 12 months post-enrollment., 12 months post-enrollment|Retention in care at study clinics, Retention in care at study clinics (and in care at any other clinic) will be measured at 12 and 24 months (measured by proportion attending club or clinic visits at months 12 and 24)., 12 and 24 months post-enrollment|Treatment interruptions, Treatment interruptions will be measured using pharmacy refill data., 0-24 months post-enrollment|ART adherence using urine tenofovir rapid assays, ART adherence will be measured using urine tenofovir rapid assays to detect Tenofovir concentrations in participants., 12 and 24 months post-enrollment|ART adherence using pharmacy data, ART adherence will be measured using medication possession ratio calculated from pharmacy refill data., 12 and 24 months post-enrollment|Success in HIV self-management of care, This outcome will be assessed with the self-regulatory processes 4-item scale, which includes these items:

I closely monitor whether I take all my ARVs every day (never - always) I make sure that I get new ARVs at the clinic before my ARVs are finished (never - always) If I notice that I have not taken my ARVs or I have taken them too late, I think about what the reason for that was and how I can prevent that from happening again (never - always) I watch carefully that I take all my ARVs every day (never - always)

Potential responses are given on a scale from 'never' (1) to 'always' (5). The minimum score is 4 and the maximum score is 20. Higher scores are associated with more successful HIV self-management of care., 12 and 24 months post-enrollment