HivNCT05938621
Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers
A study testing behavioral therapy and education in people with Hiv, run by Vanderbilt University Medical Center at 1 site in Mozambique.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- behavioral therapy and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,448 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Dec 2023to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult individuals, 18 years of age or older;
- working as physicians, nurses, medical technicians, health counselors, community health care workers, or other clinical and non-clinical staff (e.g., receptionists, data entry clerk) who provide health services to adults living with HIV at one of the four study sites;
- willing to be followed as a study participant during the 6-month study period, and does not intend to transfer to another health facility (HF) during the study period (per investigator's assessment at time of recruitment), as self-reported.
- Be able to read and write in Portuguese, as self-reported.
- Adult individuals, 18 years of age or older
- Active in care (i.e., not in default)
- Receiving HIV care and treatment at one of the four study sites.
Who cannot join
- Those who are not permanent members of the health facility staff (i.e., floating providers that work at multiple sites in a given week);
- Any clinical or mental condition, including the influence of drugs or alcohol at the time of study recruitment, that as per the investigator's opinion/assessment, would preclude the provision of informed consent or make study participation unsafe or unethical;
- Individuals working in the health facility but from the following cadres: drivers, security personnel, and workers with no patient-facing roles.
- Patient Criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Hiv
- Being tested
- behavioral therapy and education
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral therapy and educationBehavioural
Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Health care providers in this arm will receive no intervention |
| Resilience intervention | Experimental | Providers in this arm will receive training to improve their resilience and well-being Receives: Behavioral: behavioral therapy and education |
| Resilience and Stigma group | Experimental | 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. Receives: Behavioral: behavioral therapy and education |
| Anti-stigma group | Experimental | 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. Receives: Behavioral: behavioral therapy and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Dec 2023
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Audet, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938621
- Sponsor's protocol ID
- R34MH127975
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers
- ClinicalTrials.gov ID
- NCT05938621
- Acronym / sponsor ID
- R34MH127975
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,448 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Health care providers in this arm will receive no intervention |
| Resilience intervention | Experimental | Behavioral: behavioral therapy and educationProviders in this arm will receive training to improve their resilience and well-being |
| Resilience and Stigma group | Experimental | Behavioral: behavioral therapy and educationProviders 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. |
| Anti-stigma group | Experimental | Behavioral: behavioral therapy and educationProviders 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult individuals, 18 years of age or older;
- working as physicians, nurses, medical technicians, health counselors, community health care workers, or other clinical and non-clinical staff (e.g., receptionists, data entry clerk) who provide health services to adults living with HIV at one of the four study sites;
- willing to be followed as a study participant during the 6-month study period, and does not intend to transfer to another health facility (HF) during the study period (per investigator's assessment at time of recruitment), as self-reported.
- Be able to read and write in Portuguese, as self-reported.
- Adult individuals, 18 years of age or older
Key exclusion criteria (4 listed)
- Those who are not permanent members of the health facility staff (i.e., floating providers that work at multiple sites in a given week);
- Any clinical or mental condition, including the influence of drugs or alcohol at the time of study recruitment, that as per the investigator's opinion/assessment, would preclude the provision of informed consent or make study participation unsafe or unethical;
- Individuals working in the health facility but from the following cadres: drivers, security personnel, and workers with no patient-facing roles.
- Patient Criteria
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 |
|---|---|---|
| behavioral therapy and educationSessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. | Behavioural | Anti-stigma group, Resilience and Stigma group, Resilience intervention |
Primary outcome
Burnout
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Hiv
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral therapy and education in people with Hiv, run by Vanderbilt University Medical Center at 1 site in Mozambique.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 Mozambique. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Burnout (time frame: 6 months). 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 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.