DepressionNCT07032363
Implementing Depression and Adherence Treatment
A study testing Core Implementation Strategies and Enhanced Implementation Strategies in people with Depression and HIV, run by University of Miami at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, HIV, Adherence, Treatment
- What is being tested?
- Core Implementation Strategies and Enhanced Implementation Strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Africa
- Study dates
- 20 May 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Are 18 years of age or older and
- Have a detectable HIV viral load (operationalized as the lower limit of detection on the standard test is used at the local clinic), or presumed detectable viral load per clinic standards
- Screen in for depression via the PHQ (following detection standards set in clinics)
Who cannot join
- -Children below the age of 18 will not be included in the proposed study for adults.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town
Cape Town
About this study
Official title: Implementing Depression and Adherence Treatment in South Africa HIV Care
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)?
Read more
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.
Read the detailed description
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.
- Conditions
- Depression, HIV, Adherence, Treatment, AIDS
- Being tested
- Core Implementation Strategies, Enhanced Implementation Strategies
- Keywords
- implementation science, HIV, depression
- Medical subject headings
- Depression, Treatment Adherence and Compliance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Implementation StrategiesOther
- 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
Enhanced Implementation StrategiesOther
- Train the trainer
- Ongoing supervision and consultation
| Study group | Role | What they receive |
|---|---|---|
| Core | Other | Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health. Receives: Other: Core Implementation Strategies |
| Enhanced | Other | Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment. Receives: Other: Core Implementation Strategies; Other: Enhanced Implementation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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).
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start20 May 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Massachusetts General Hospital, University of Cape Town
- Responsible party
- Principal investigator, Steven Safren, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032363
- Sponsor's protocol ID
- 20241034
- Other IDs
- R01MH136972
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Everitt-Penhale B, Kagee A, Magidson JF, Joska J, Safren SA, O'Cleirigh C, Witten J, Lee JS, Andersen LS. 'I went back to being myself': acceptability of a culturally adapted task-shifted cognitive-behavioural therapy (CBT) treatment for depression (Ziphamandla) for South African HIV care settings. Psychol Health Med. 2019 Jul;24(6):680-690. doi: 10.1080/13548506.2019.1566624. Epub 2019 Jan 17.
PubMed 30652921Safren SA, Bedoya CA, O'Cleirigh C, Biello KB, Pinkston MM, Stein MD, Traeger L, Kojic E, Robbins GK, Lerner JA, Herman DS, Mimiaga MJ, Mayer KH. Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Lancet HIV. 2016 Nov;3(11):e529-e538. doi: 10.1016/S2352-3018(16)30053-4. Epub 2016 Sep 19.
PubMed 27658881Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.
PubMed 34708929Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1-10. doi: 10.1037/a0012715.
PubMed 19210012
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Depression and Adherence Treatment in South Africa HIV Care
- ClinicalTrials.gov ID
- NCT07032363
- Acronym / sponsor ID
- 20241034
- Conditions
- Depression, HIV, Adherence, Treatment, AIDS
- Keywords
- implementation science, HIV, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Massachusetts General Hospital, University of Cape Town
- Study start
- 20 May 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core | Other | Other: Core Implementation StrategiesClinics in this arm will receive strategies that involve capacity building for nurses and education on mental health. |
| Enhanced | Other | Other: Core Implementation Strategies, Other: Enhanced Implementation StrategiesClinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- Are 18 years of age or older and
- Have a detectable HIV viral load (operationalized as the lower limit of detection on the standard test is used at the local clinic), or presumed detectable viral load per clinic standards
- Screen in for depression via the PHQ (following detection standards set in clinics)
Key exclusion criteria (1 listed)
- -Children below the age of 18 will not be included in the proposed study for adults.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core 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 | Other | Core, Enhanced |
| Enhanced Implementation Strategies* Train the trainer * Ongoing supervision and consultation | Other | Enhanced |
Primary outcome
Reach of depression treatment
Time frame: 1 year
Proportion of patients who start an evidence-based treatment for depression out of patients identified with positive depression and a detectable viral load
2 secondary outcomes
Depression
Time frame: 1 year
Viral undetectability
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 30652921Everitt-Penhale B, Kagee A, Magidson JF, Joska J, Safren SA, O'Cleirigh C, Witten J, Lee JS, Andersen LS. 'I went back to being myself': acceptability of a culturally adapted task-shifted cognitive-behavioural therapy (CBT) treatment for depression (Ziphamandla) for South African HIV care settings. Psychol Health Med. 2019 Jul;24(6):680-690. doi: 10.1080/13548506.2019.1566624. Epub 2019 Jan 17.
- Background: PubMed 27658881Safren SA, Bedoya CA, O'Cleirigh C, Biello KB, Pinkston MM, Stein MD, Traeger L, Kojic E, Robbins GK, Lerner JA, Herman DS, Mimiaga MJ, Mayer KH. Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Lancet HIV. 2016 Nov;3(11):e529-e538. doi: 10.1016/S2352-3018(16)30053-4. Epub 2016 Sep 19.
- Background: PubMed 34708929Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.
- Background: PubMed 19210012Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1-10. doi: 10.1037/a0012715.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Implementation Strategies and Enhanced Implementation Strategies in people with Depression and HIV, run by University of Miami at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven A Safren, PhD (305-243-3471, ssafren@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of depression treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07032363, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.