An interventional study of behavioral therapy and education in Hiv, sponsored by Vanderbilt University Medical Center. Completed at 1 site in Mozambique. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Supportive care
Health care workers' negative behavior towards patients (likely a reflection of low job satisfaction, frustration with delivering HIV care and treatment in extremely resource-limited settings, and burnout) is one of the primary reasons people living with HIV abandon treatment in Mozambique. The purpose of this proposal is to test the impact and implementation of a provider resilience intervention and an anti-stigma intervention, individually and in combination, using a randomized controlled trial design at four health facilities. This potentially high-impact intervention offers the opportunity to test a low-cost, provider-focused approach to improving HIV treatment that, if proven effective at increasing adherence and retention in care, could be tested in a fully powered R01 trial in Mozambique.
Mozambique has made progress towards their 95-95-95 goals, yet only 65% of people newly initiated in HIV treatment remain in care at 12 months. HIV treatment adherence has been undermined by a lack of compassionate health care service delivery. People living with HIV in our study region of Zambezia province report being treated disrespectfully by health care workers as one of the leading causes of treatment abandonment. Common complaints include insulting patients' intellectual capacity, ignoring concerns with side effects or co-occurring infections, and refusing to treat patients seen as "unworthy". While health care worker behavior is appalling, it is likely a reflection of high rates of burnout, job dissatisfaction, and frustration with patients they perceive to be uncooperative.
The implementation of Estamos Juntos (We are Together) will allow us to test a multiprong intervention designed to address provider-barriers to delivering compassionate care via two synergistic components: (1) Resilience and well-being training for health care providers who have expressed low job satisfaction, frustration with delivering care in an extremely resource-limited setting, and burnout; and (2) Anti-stigma training for health care providers who see those with low socioeconomic status, low levels of education, and those living with HIV as "lesser-than" themselves. We propose to pilot test the implementation and impact of each psychosocial intervention individually, and in combination, using a randomized controlled trial design at four health facilities. We hypothesize that the facility where health care workers receive both resilience and anti-stigma training will see the greatest change in health care worker outcomes, including decreased stigmatizing attitudes, emotional exhaustion, and depersonalize of their patients, as well as increased resilience and job satisfaction. Patients receiving care and treatment from intervention providers will show increased retention and medication adherence, as well as improvements in health care services satisfaction, medical mistrust, and perceived stigma from health care providers.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 28,448 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Provider Criteria
Inclusion Criteria:
Exclusion Criteria:
Patient Criteria
Inclusion:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Health care providers in this arm will receive no intervention
Providers in this arm will receive training to improve their resilience and well-being
Behavioral: behavioral therapy and education
Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients.
Behavioral: behavioral therapy and education
Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed.
Behavioral: behavioral therapy and education
Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
Burnout
We assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative.
Time frame: 6 months
We recruited 25 health care workers from each of four health facilities. Health care workers consented to participate and interacted with the study team. All eligible patients who they treated during the subsequent 6 months were included in the clinical outcome data.
| Milestone | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group |
|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 |
| Number of patients receiving care | 4597 | 12904 | 6324 | 4523 |
| Completed | 24 | 20 | 23 | 23 |
| Not completed | 1 | 5 | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 5 | 2 | 2 |
We assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative.
| units on a scale | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group |
|---|---|---|---|---|
| Burnout | -2.0 (-10.9 to 9.5) | -5.9 (-8.2 to -2.0) | -5.3 (-13.8 to 2.0) | -3.9 (-13.8 to 2.0) |
Collected over The data were collected from providers over a six-month period. Per protocol, adverse event data were not collected from patients.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Resilience Intervention | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Resilience and Stigma Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Anti-stigma Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Provider Baseline Data and Patient Data are collapsed together here.
| Age, Continuous(years) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Mean | 33.5 ± 7.09 | 33.8 ± 8.88 | 35.2 ± 8.18 | 33.7 ± 6.67 | 34.1 ± 7.67 |
| Age, Continuous(years) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Mean | 32.3 ± 10.60 | 29.7 ± 18.86 | 32.11 ± 10.49 | 30.6 ± 10.11 | 30.8 ± 14.91 |
| Sex: Female, Male(Participants) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Female | 16 | 13 | 19 | 15 | 63 |
| Male | 9 | 12 | 6 | 10 | 37 |
| Sex: Female, Male(Participants) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Female | 3044 | 9058 | 4379 | 2926 | 19407 |
| Male | 1553 | 3846 | 1945 | 1597 | 8941 |
| Race (NIH/OMB)(Participants) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4622 | 12929 | 6349 | 4548 | 28448 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Mozambique | 4622 | 12929 | 6349 | 4548 | 28448 |
| Number of Years Working in this Health Facility(years) | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Mean | 3.4 ± 1.95 | 6.1 ± 6.05 | 5.5 ± 3.70 | 4.2 ± 3.09 | 4.8 ± 4.07 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Mozambique is in the process of determining what IPD can be shared to researchers not on the approved study team. Once we know their new legal process we will update this plan.
Ran from Dec 2023 to primary completion in Feb 2025, 14 months.
Results were first posted in Sep 2025, 6 months after primary completion.
Of 641 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 14 months is below that.
Counting every sponsor, half of 647 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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