An interventional study of Core Implementation Strategies and Enhanced Implementation Strategies in Depression, HIV and Adherence, Treatment, sponsored by University of Miami. Recruiting at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Miami · Not applicable, Interventional, and Health services research
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Among 27 studies in Depression by University of Miami — 7 open to participants now, 8 under way, none of them phase 3. Depression · University of Miami.
Among the 27 studies in Depression by University of Miami, this one is the 23rd largest by planned enrollment of the 26 interventional ones that give a count, is the only one that started in 2026, is one of 24 with no phase, and was the 27th registered.
8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.
Browse Depression studies →7 of the 27 studies in Depression by University of Miami are open now, in 2 countries. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 14–20 · Healthy volunteers
University of Miami · Sites in United States
Ages 13–19
University of Miami · Sites in United States
Ages 18–50 · Healthy volunteers
University of Miami · Sites in United States
Ages 12–16 · Healthy volunteers
University of Miami · Sites in United States
Ages 18–59
By country, each count listing its studies:
Of the 1,090 Depression studies recruiting now, 470 (43%) set no upper age limit and 520 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 10 is below the median of 81 across 7,074 interventional studies indexed under Depression.
Median enrollment 70 across the 26 interventional studies, 1,008 across the 1 observational. Of the 17 that completed or were terminated, 2 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Miami is the lead sponsor of 842 studies on the registry; 166 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
3 of the studies in Depression by University of Miami that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05935644University of MiamiORCHID: An Online Intervention for Persons With HIV (Miami) | 2027-04-27 |
| NCT03870360University of MiamiPreventing Anxiety and Depression in Older Hispanics | 2027-06-01 |
| NCT05453513University of MiamiThe Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV | 2027-07-30 |
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Among the 27 studies in Depression by University of Miami, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression. The main questions it aims to answer are:
What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)?
Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance.
Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.
Objectives:
Our primary objective is to compare a core set to an enhanced set of implementation strategies for extending the reach of evidence-based treatments for depression to patients with uncontrolled HIV in South Africa (SA) HIV care settings. Using RE-AIM as the implementation outcome framework, the primary outcome is reach, defined as the percent of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy).
To further inform optimal implementation strategies, we will also examine possible moderators and mediators of implementation outcomes including the hypothesized mechanisms of the Implementation Research Logic Model (IRLM) (e.g., clinic level variables, self-efficacy, capacity for training, intervention delivery).
Our secondary objectives are effectiveness focused in order to assess differences in patient-level depression and HIV outcomes when using the enhanced versus the core set of strategies.
Study Procedures:
This is a cluster (clinic based), staged, randomized implementation trial, in 10 public primary HIV care clinics surrounding Cape Town, SA. We will compare a core and an enhanced set of implementation strategies. Because this is a type 3 hybrid implementation/effectiveness study, we are primarily examining implementation outcomes (i.e., reach). However, we will also collect information about whether the effectiveness of the interventions varies as a function of the implementation strategies used to support them. The primary "participants" in this trial are the 10 randomized clinics. In order to evaluate implementation and effectiveness outcomes, patient data will be extracted from clinic records. Research materials that we will extract will consist of 1) PHQ data to assess depression, 2) records relating to depression treatment (e.g., medications prescribed, psychosocial treatments received), 3) HIV viral load lab results 4) Demographic information, and 5) HIV treatment history (e.g. number of years living with HIV, other HIV history). Data will be abstracted from records at regular intervals for one year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for Clinics (the primary "participants"):
Inclusion Criteria for Patient-level Outcomes:
Although the unit of randomization is at the clinic level, the study will be looking at adult patient level data at each clinic. All patients engaged in care at one of the 10 primary care/HIV treatment clinics in the study will be included if they:
Exclusion Criteria:
-Children below the age of 18 will not be included in the proposed study for adults.
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.
Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.
Other: Core Implementation Strategies
Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.
Other: Core Implementation Strategies · Other: Enhanced Implementation Strategies
* Task Sharing/Revise Professional Roles * Distribute educational materials/Dynamic Training/Address Stigma * Clinician Implementation Team Meetings * Partner with CoCT DoH * Champion * Audit and Feedback * Stage Scale Up/Tailoring
* Train the trainer * Ongoing supervision and consultation
Reach of depression treatment
Proportion of patients who start an evidence-based treatment for depression out of patients identified with positive depression and a detectable viral load
Time frame: 1 year
Depression
Of those identified as having depression and detectable virus, the percentage of patients, after one year, who are considered depression treatment responders (categorized as a responder if they achieve significant reduction in symptoms on the PHQ or if they no longer meet clinical criteria for depression).
Time frame: 1 year
Viral undetectability
Of those identified with detectable virus and depression, the percentage of patients who attain an undetectable HIV RNA viral load across the two arms.
Time frame: 1 year
Plan to share: Yes — Effectiveness outcome data: We will extract medical record data from participants at the HIV clinics who have detectable, or presumed detectable, HIV and screen positive for depression. This will include depression, HIV RNA viral load, and demographic information.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: The earliest possible start of data entry for implementation outcomes would be July 2026. After this, available data will be deposited every six months thereafter following the usual NDA data submission dates, as new data are collected. The research community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now. (Unending).
Access criteria: Data will be made available through NIMH's Data Archive (NDA). To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. We do not anticipate that any data will need to be restricted.
Started May 2026 (actual). Primary completion is estimated for May 2030, 48 months after the start.
Of 3,476 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 48 months is above that.
Counting every sponsor, half of 3,574 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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