Depression - Major Depressive DisorderNCT06951542
HIV-Mental Illness Stigma Reduction and Outcomes in Malawi
A study testing Stigma Reduction Counseling in people with Depression - Major Depressive Disorder and HIV, run by University of Pennsylvania at 2 sites in Malawi.
Trial summary
The overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, HIV, Health Condition Stigma
- What is being tested?
- Stigma Reduction Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesMalawi
- Study dates
- 4 May 2026to Jul 2027
- 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
- Living with HIV and receiving ART at Salima or Mulanje District Hospital
- Adult (18+ years)
- Elevated depressive symptoms (PHQ-9 Score ≥5)
Who cannot join
- Pregnant women
- Severe mental or physical illness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving HIV and Depression Outcomes by Reducing HIV-Mental Illness Stigma in Salima and Mulanje Districts: Pilot Trial
The overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Participant surveys and abstracted clinical data related to HIV and depression care will assess the effectiveness of the intervention.
Read the detailed description
Stigma and depression are associated with increased HIV-related mortality and morbidity; as depression treatment is increasingly integrated into HIV care, addressing HIV stigma, mental illness stigma, and intersectional HIV-mental illness stigma is crucial. The Malawi Ministry of Health has recently integrated depression screening and treatment into the antiretroviral therapy (ART) departments of 12 District Hospitals across the country, including Salima and Mulanje District Hospital. Through this program, adults living with HIV are now screened with the Patient Health Questionnaire-9 (PHQ-9) and depressed patients are prescribed antidepressants using Measurement-based Care (MBC) or referred for Friendship Bench (FB) problem-solving therapy.
With this study the investigators aim to augment the existing depression treatment program at Salima and Mulanje District Hospitals with counselling to help address and reduce stigma. The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Ultimately, this study will evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the HIV-mental illness stigma-reduction intervention as part of depression treatment integrated into HIV care at Salima and Mulanje district hospitals using a pilot trial, with a multiple-baseline design. To achieve this goal, the investigators will enroll 200 depressed adults living with HIV in the trial, survey patient participants at enrollment, 3-months and 6-months, abstract clinical data related to HIV and depression care, track engagement in the stigma reduction intervention, assess intervention sessions for fidelity to the intervention protocol and conduct qualitative interviews with a sub-set of patients who received the stigma-reduction intervention (n=20) and healthcare providers including HTC counselors (N=4), ART providers (N=10), Friendship Bench counselors (N=6), and counselors (n=4) who deliver the stigma-reduction intervention.
This innovative research will a) address HIV, MI and intersectional stigma while leveraging existing mental health services for people living with HIV, b) lay the ground-work for a multi-level stigma-reduction intervention package, and c) yield detailed insights into barriers and facilitators of implementing stigma-reduction interventions in low-resource settings.
- Being tested
- Stigma Reduction Counseling
- Keywords
- Malawi, Health Condition Stigma, Stigma, Measurement-based Care (MBC), Friendship Bench (FB) Therapy, Salima, Mulanje, Mental Illness Stigma, HIV Stigma, Stigma Reduction Counseling, Stigma Intervention, Multi-Level Stigma Reduction, HIV Care Engagement, HIV, Depression
- Medical subject headings
- Social Stigma, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma Reduction CounselingBehavioural
The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation Phase | No intervention | In the pre-implementation phase, antiretroviral therapy (ART) providers will screen and treat patients at ART for depression as is now standard practice. Namely, patients will be screened using the Patient Health Questionnaire-9 (PHQ-9) and depressed patients will be treated with Measurement-based Care (MBC) and/or Friendship Bench (FB) problem-solving therapy. At each monthly ART appointment, providers assess patients' depressive symptoms and continue depression treatment as clinically indicated. |
| Intervention Implementation Phase | Experimental | In the intervention implementation phase, patients at antiretroviral therapy (ART) will be screened and treated for depression as described and assessed for the study enrollment as in the pre-implementation phase. Depressed patients will be referred to counselors to receive the stigma-reduction intervention sessions. Stigma-reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Intervention sessions will be audio-recorded (with participants' consent) as part of the fidelity assessment. Receives: Behavioral: Stigma Reduction Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will measure feasibility by conducting qualitative interviews (guided by Proctor's Outcomes for Implementation Research) with providers and counselors who deliver the stigma-reduction intervention. This interview will consist of 12 open-ended questions (with subparts) meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.
Measured: Upon the completion of intervention delivery for all patients (assessed up to 6 months)
Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will conduct audio-recorded semi-structured qualitative interviews with patients enrolled in the study who initiated depression treatment during the implementation phase. The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with patients. The interviews will consist of 11 open-ended questions (with subparts) which are designed to elicit a response from the patient about their perceived acceptability of the intervention. This includes how helpful patients believed the intervention was in improving their mental health and feelings of stigma, barriers and facilitators to engagement in the intervention, and perceived areas of improvement and harm of the intervention.
Measured: After completion of all intervention sessions, an average of 6 months
Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will measure acceptability of the intervention through a quantitative questionnaire, the Client Satisfaction Questionnaire-8. Each of the 8 questions are scored from 1-4 with higher ratings indicating greater satisfaction with the intervention.
Measured: After completion of each intervention session
Provider Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with counselors and providers who deliver the stigma-reduction intervention to assess acceptability to providers. This interview will consist of 12 open-ended questions meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.
Measured: Upon intervention delivery completion for all patients (assessed up to 6 months)
Fidelity of the Content of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will monitor fidelity in the content of the intervention protocol by assessing the extent to which providers correctly deliver depression treatment and stigma-reduction intervention by reviewing audio-recorded intervention sessions with patients using a fidelity checklist.
Measured: Through study completion, an average of 6 months
Fidelity of the Coverage of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will monitor fidelity in the coverage of the intervention protocol using clinical and program data to measure the percentage of patients who receive the correct depression treatment and the stigma-reduction intervention.
Measured: Through study completion, an average of 6 months
Fidelity of the Frequency of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will monitor fidelity in the frequency of the intervention protocol using clinical and program data to measure the number of completed depression treatment appointments and stigma-reduction intervention sessions, as well as the number of patients who complete the depression treatment and stigma-reduction intervention.
Measured: Through study completion, an average of 6 months
Fidelity of the Duration of the HIV-Mental Illness Stigma Reduction Intervention
The investigators will monitor fidelity in the duration of the intervention protocol using clinical and program data to measure the number of depression treatment and stigma-reduction intervention sessions patients receive over their first six months in HIV care and the attendance of at least 75% of scheduled depression treatment appointments and stigma-reduction intervention sessions (y/n) over the first six months in HIV care.
Measured: Through study completion, an average of 6 months
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
Internalized AIDS-Related Stigma Scale will be used to assess patient's level of internalized HIV stigma. Patients rate their agreement of 6 statements. Items are scored with a 0 for disagree or 1 for agree. A higher total scores indicate greater internalized stigma.
Measured: At enrollment, 3-months post enrollment, and 6-months post enrollment
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
The Adapted Internalized Stigma of Mental Illness Scale will be used to assess patient's level of internalized HIV stigma. The Adapted Internalized Stigma of Mental Illness Scale measures patient's internalized stigma with regard to their mental health. Patients rate their agreement with 29 statements across five subscales: alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance. The scale for scoring items indicates a 0 for "strongly disagree" to a 4 for "strongly agree". A higher total scores indicate greater internalized stigma.
Measured: At enrollment, 3-months post enrollment, and 6-months post enrollment
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Address Depression
The investigators will utilize the Patient Health Questionnaire (PHQ-9), completed by providers, to measure patients' severity of depression. Patients will indicate how often they experienced 9 depression symptoms in the last 2 weeks. The scale for scoring items indicates a 0 for "not at all" and a 3 for "nearly every day". Higher total scores indicate greater depression severity. Scores of 5 or more are indicative of mild to severe depression.
Measured: At enrollment, 3-months post enrollment, and 6-months post enrollment
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
Clinical data related to antiretroviral therapy appointment attendance will be abstracted.
Measured: Through study completion, an average of 6 months
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
Clinical data related to antiretroviral therapy pill counts will be abstracted.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start4 May 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a pilot trial, with a multiple baseline design to enroll 200 depressed PLHIV at the study sites who will either receive usual depression care during the pre-implementation phase or enhance usual depression care (+ stigma-reduction counseling) during the implementation phase. Using the multiple baseline design with two phases (a pre-implementation phase and an intervention implementation phase), the intervention launches earlier at Clinic A than Clinic B, based on random selection. Staggering the launch of the implementation phase will allow for assessment of and potential correction for any secular trend in outcomes.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Melissa Stockton, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951542
- Sponsor's protocol ID
- 857336
- Other IDs
- 7K01MH130226-03
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV and Depression Outcomes by Reducing HIV-Mental Illness Stigma in Salima and Mulanje Districts: Pilot Trial
- ClinicalTrials.gov ID
- NCT06951542
- Acronym / sponsor ID
- 857336
- Keywords
- Malawi, Health Condition Stigma, Stigma, Measurement-based Care (MBC), Friendship Bench (FB) Therapy, Salima, Mulanje, Mental Illness Stigma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Apr 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 overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Participant surveys and abstracted clinical data related to HIV and depression care will assess the effectiveness of the intervention.
Detailed description
Stigma and depression are associated with increased HIV-related mortality and morbidity; as depression treatment is increasingly integrated into HIV care, addressing HIV stigma, mental illness stigma, and intersectional HIV-mental illness stigma is crucial. The Malawi Ministry of Health has recently integrated depression screening and treatment into the antiretroviral therapy (ART) departments of 12 District Hospitals across the country, including Salima and Mulanje District Hospital. Through this program, adults living with HIV are now screened with the Patient Health Questionnaire-9 (PHQ-9) and depressed patients are prescribed antidepressants using Measurement-based Care (MBC) or referred for Friendship Bench (FB) problem-solving therapy.
With this study the investigators aim to augment the existing depression treatment program at Salima and Mulanje District Hospitals with counselling to help address and reduce stigma. The stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Ultimately, this study will evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the HIV-mental illness stigma-reduction intervention as part of depression treatment integrated into HIV care at Salima and Mulanje district hospitals using a pilot trial, with a multiple-baseline design. To achieve this goal, the investigators will enroll 200 depressed adults living with HIV in the trial, survey patient participants at enrollment, 3-months and 6-months, abstract clinical data related to HIV and depression care, track engagement in the stigma reduction intervention, assess intervention sessions for fidelity to the intervention protocol and conduct qualitative interviews with a sub-set of patients who received the stigma-reduction intervention (n=20) and healthcare providers including HTC counselors (N=4), ART providers (N=10), Friendship Bench counselors (N=6), and counselors (n=4) who deliver the stigma-reduction intervention.
This innovative research will a) address HIV, MI and intersectional stigma while leveraging existing mental health services for people living with HIV, b) lay the ground-work for a multi-level stigma-reduction intervention package, and c) yield detailed insights into barriers and facilitators of implementing stigma-reduction interventions in low-resource settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct a pilot trial, with a multiple baseline design to enroll 200 depressed PLHIV at the study sites who will either receive usual depression care during the pre-implementation phase or enhance usual depression care (+ stigma-reduction counseling) during the implementation phase. Using the multiple baseline design with two phases (a pre-implementation phase and an intervention implementation phase), the intervention launches earlier at Clinic A than Clinic B, based on random selection. Staggering the launch of the implementation phase will allow for assessment of and potential correction for any secular trend in outcomes.
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Phase | No intervention | –In the pre-implementation phase, antiretroviral therapy (ART) providers will screen and treat patients at ART for depression as is now standard practice. Namely, patients will be screened using the Patient Health Questionnaire-9 (PHQ-9) and depressed patients will be treated with Measurement-based Care (MBC) and/or Friendship Bench (FB) problem-solving therapy. At each monthly ART appointment, providers assess patients' depressive symptoms and continue depression treatment as clinically indicated. |
| Intervention Implementation Phase | Experimental | Behavioral: Stigma Reduction CounselingIn the intervention implementation phase, patients at antiretroviral therapy (ART) will be screened and treated for depression as described and assessed for the study enrollment as in the pre-implementation phase. Depressed patients will be referred to counselors to receive the stigma-reduction intervention sessions. Stigma-reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. Intervention sessions will be audio-recorded (with participants' consent) as part of the fidelity assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Living with HIV and receiving ART at Salima or Mulanje District Hospital
- Adult (18+ years)
- Elevated depressive symptoms (PHQ-9 Score ≥5)
Key exclusion criteria (2 listed)
- Pregnant women
- Severe mental or physical illness
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 |
|---|---|---|
| Stigma Reduction CounselingThe stigma reduction counseling sessions will include psychoeducation and activities to challenge myths and stereotypes, cope with experiences of discrimination, and overcome self-stigma. | Behavioural | Intervention Implementation Phase |
Primary outcome
Feasibility of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Upon the completion of intervention delivery for all patients (assessed up to 6 months)
The investigators will measure feasibility by conducting qualitative interviews (guided by Proctor's Outcomes for Implementation Research) with providers and counselors who deliver the stigma-reduction intervention. This interview will consist of 12 open-ended questions (with subparts) meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.
Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: After completion of all intervention sessions, an average of 6 months
The investigators will conduct audio-recorded semi-structured qualitative interviews with patients enrolled in the study who initiated depression treatment during the implementation phase. The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with patients. The interviews will consist of 11 open-ended questions (with subparts) which are designed to elicit a response from the patient about their perceived acceptability of the intervention. This includes how helpful patients believed the intervention was in improving their mental health and feelings of stigma, barriers and facilitators to engagement in the intervention, and perceived areas of improvement and harm of the intervention.
Patient Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: After completion of each intervention session
The investigators will measure acceptability of the intervention through a quantitative questionnaire, the Client Satisfaction Questionnaire-8. Each of the 8 questions are scored from 1-4 with higher ratings indicating greater satisfaction with the intervention.
Provider Acceptability of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Upon intervention delivery completion for all patients (assessed up to 6 months)
The investigators will use interview guides (using guidance from Proctor's Outcomes for Implementation Research) to conduct qualitative interviews with counselors and providers who deliver the stigma-reduction intervention to assess acceptability to providers. This interview will consist of 12 open-ended questions meant to elicit a response from providers about their perceived changes in their patients' attitudes/well-being, their personal comfort level with delivering the intervention and competency, their training satisfaction, their recommendations for improving the intervention, and their perceived barriers and facilitators to implementation of the intervention.
Fidelity of the Content of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Through study completion, an average of 6 months
The investigators will monitor fidelity in the content of the intervention protocol by assessing the extent to which providers correctly deliver depression treatment and stigma-reduction intervention by reviewing audio-recorded intervention sessions with patients using a fidelity checklist.
Fidelity of the Coverage of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Through study completion, an average of 6 months
The investigators will monitor fidelity in the coverage of the intervention protocol using clinical and program data to measure the percentage of patients who receive the correct depression treatment and the stigma-reduction intervention.
Fidelity of the Frequency of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Through study completion, an average of 6 months
The investigators will monitor fidelity in the frequency of the intervention protocol using clinical and program data to measure the number of completed depression treatment appointments and stigma-reduction intervention sessions, as well as the number of patients who complete the depression treatment and stigma-reduction intervention.
Fidelity of the Duration of the HIV-Mental Illness Stigma Reduction Intervention
Time frame: Through study completion, an average of 6 months
The investigators will monitor fidelity in the duration of the intervention protocol using clinical and program data to measure the number of depression treatment and stigma-reduction intervention sessions patients receive over their first six months in HIV care and the attendance of at least 75% of scheduled depression treatment appointments and stigma-reduction intervention sessions (y/n) over the first six months in HIV care.
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
Time frame: At enrollment, 3-months post enrollment, and 6-months post enrollment
Internalized AIDS-Related Stigma Scale will be used to assess patient's level of internalized HIV stigma. Patients rate their agreement of 6 statements. Items are scored with a 0 for disagree or 1 for agree. A higher total scores indicate greater internalized stigma.
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Reduce Stigma
Time frame: At enrollment, 3-months post enrollment, and 6-months post enrollment
The Adapted Internalized Stigma of Mental Illness Scale will be used to assess patient's level of internalized HIV stigma. The Adapted Internalized Stigma of Mental Illness Scale measures patient's internalized stigma with regard to their mental health. Patients rate their agreement with 29 statements across five subscales: alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance. The scale for scoring items indicates a 0 for "strongly disagree" to a 4 for "strongly agree". A higher total scores indicate greater internalized stigma.
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Address Depression
Time frame: At enrollment, 3-months post enrollment, and 6-months post enrollment
The investigators will utilize the Patient Health Questionnaire (PHQ-9), completed by providers, to measure patients' severity of depression. Patients will indicate how often they experienced 9 depression symptoms in the last 2 weeks. The scale for scoring items indicates a 0 for "not at all" and a 3 for "nearly every day". Higher total scores indicate greater depression severity. Scores of 5 or more are indicative of mild to severe depression.
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
Time frame: Through study completion, an average of 6 months
Clinical data related to antiretroviral therapy appointment attendance will be abstracted.
Preliminary Effectiveness of The HIV-Mental Illness Stigma Reduction Intervention to Improve HIV Care Engagement
Time frame: Through study completion, an average of 6 months
Clinical data related to antiretroviral therapy pill counts will be abstracted.
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 10 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stigma Reduction Counseling in people with Depression - Major Depressive Disorder and HIV, run by University of Pennsylvania at 2 sites in Malawi.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the HIV-Mental Illness Stigma Reduction Intervention (time frame: Upon the completion of intervention delivery for all patients (assessed up to 6 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.