HIVNCT07706634
Care Disengagement Prevention in PLWH in Indonesia
A study testing Stigma reduction in people with HIV and Indonesia, run by University of California, Los Angeles at 1 site in Indonesia.
Trial summary
This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Indonesia, Engagement in HIV Care
- What is being tested?
- Stigma reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Feb 2026to 31 Jan 2028
- 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
- Able to give informed consent
- Able to attend study visits
Who cannot join
- Condition that prevents full participation in the study such as neurological disease, major depression or cardiovascular disease
- Unable to communicate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
University of Indonesia Hospital
Depok, West Java, 16424
Wei-Ti Chen, RN, CNM, PhD, FAAN, 310-206-8539, wchen@sonnet.ucla.edu
About this study
Official title: Care Disengagement Prevention in Treatment Naive Indonesians Living With HIV
This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status.
Read the detailed description
This project focuses on an innovative evidence-based stigma-reduction intervention that addresses HIV care engagement, which is key for reducing HIV transmission. This work is directly relevant to the U.S., including the Ending the HIV Epidemic (EHE) initiative, as stigma remains a key barrier to care engagement across variable populations. U.S. communities, including faith-based populations, need to strengthen retention across the HIV care continuum to reduce HIV transmission and eventually eradicate HIV infection from the U.S. However, there is a dearth of information related to strategies to reduce HIV stigma among Muslims who are living with HIV in the U.S., who are both widely distributed and in concentrations that make studies impossible to carry out over short time frames. As the world's largest Muslim-majority country, accounting for 13% of the global Muslim population, Indonesia provides a critical context for developing culturally grounded stigma-reduction interventions to improve HIV treatment engagement. In Asia, the population size of people living with HIV (PLH) in Indonesia is second only to that in India and China. According to recent estimates from UNAIDS, while there were an estimated 540,000 PLH in Indonesia in 2022, only 179,659 (33.27%) were reportedly on antiretroviral therapy (ART), 36,821 (6.82%) were regularly tested for viral load, and 33,395 (6.18%) achieved viral suppression. The majority of Indonesian PLHs are lost across the HIV care continuum, even after the government's Strategic Use of Antiretroviral Therapy program launched in 2013. The reasons for this failure to retain PLH in care include insufficient knowledge and limited accessibility and affordability of care, but the most prominent barrier is the fear of stigma. Stigma not only deters PLH from seeking care but also strains patient-provider relationships. Indeed, stigma is considered the greatest barrier to ending HIV in Indonesia whose cultural meanings surrounding HIV are rooted in the local "religious-familial" complex. The scientific premise is that HIV stigma remains rampant in Indonesia, where Islamic doctrine is prominent, with severe negative impacts on treatment engagement. This study addresses the critical need to increase treatment engagement among PLH and retain them in care by addressing the stigma surrounding HIV. Study aims are to adapt an evidence-based stigma reduction intervention and to test the feasibility, acceptability, and preliminary efficacy of the adapted intervention for stigma reduction and care engagement in a Muslim-dominant population. This study will provide transferable insights to inform stigma-reduction strategies and improve HIV care engagement in the U.S. context. The project's key innovations are culturally grounded modules informed by Islamic teachings on justice, compassion, and mindful prayer, while employing a nurse-led, low-intensity, four-session intervention model designed for scalability in resource-poor settings in the U.S. The project findings will advance the understanding of stigma reduction tools used to prevent leakage from the HIV care continuum and ultimately help protect the health of Americans.
- Conditions
- HIV, Indonesia, Engagement in HIV Care, Stigma
- Being tested
- Stigma reduction
- Keywords
- HIV, Stigma reduction
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma reductionBehavioural
The study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population.
| Study group | Role | What they receive |
|---|---|---|
| Stigma reduction | Experimental | Participants receive a stigma-reduction intervention that has been adapted for use in the target population. Receives: Behavioral: Stigma reduction |
| Treatment as Usual | No intervention | Participants receive typical services including care co-ordination and linkage to public health nurses in local communities. |
| Interview group | No intervention | With the goal of culturally adapting an existing intervention for use among people living with HIV from Indonesia, in-depth interviews are conducted with Indonesians living with HIV. Participants in the interview group are not followed for outcomes or AEs. |
| Focus Group | No intervention | Focus groups made up of Indonesians living with HIV are presented the adapted intervention. Feasibility, acceptability, and appropriateness are assessed that inform the final version of the adapted intervention for use in the target population. Participants in the focus group are not followed for outcomes or AEs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stigma Score From Baseline to End of Intervention
The Perceived Stigma Scale (PSS) of the HIV Stigma Scale will be used to measure perceived stigma. Each item is measured using a 4-point Likert scale and the scale contains four factors: personalized stigma (18 items, subscore total 18-72), disclosure concerns (12 items, subscore total 12-48), negative self-image (9 items, subscore total 9-36), and concern with public attitudes about people with HIV (12 items, subscore total 12-48). Each factor is scored separately, with total score is computed by summing all 40 items, with a minimum total PSS score of 40 and a maximum possible score of 160. Raw PSS scores were transformed into Stigma scores 1-4. Higher scores reflect higher levels of perceived stigma.
Measured: Baseline to 26 weeks
Change in Adherence From Baseline to End of Intervention
A one-item visual analog scale assesses 30-day HIV medication adherence, reported separately for each drug, along a continuum of "none of the doses" to "every dose." The maximum possible score for an individual drug item is 100 (representing 100% adherence, or "every dose"). Each drug is scored separately, with total score computed by summing all items, with a minimum total score of 0 (no medications taken) and a maximum possible score depending on the total number of medications in the participant's specific HIV regimen. Higher scores reflect higher levels of HIV medication adherence.
Measured: Baseline to 26 weeks
Level of Healthcare Engagement From Baseline to End of Intervention as Measured by Missed or Delayed Clinic Visits
Proportions of missed or delayed clinic visits for HIV care will be calculated for each participant. Minimum scores are 0 (missed or delayed zero scheduled appointments) and maximum score is 1 (missed or delayed every single scheduled appointment). The score is derived by dividing the number of missed/delayed visits by the total number of scheduled visits for that specific participant. Higher scores indicate lower levels of HIV healthcare engagement.
Measured: Baseline to 26 weeks
Changes in Patient Activation from Baseline to End of Intervention
The Patient Activation Measure-Short Form will be used to measure knowledge, skill, and confidence managing health. Statements are rated on a 4-point scale from "strongly disagree" to "strongly agree". Scores range from 0 to 100, which corresponds to one of four activation levels: Level 1 (0-47.0), Level 2 (47.1-55.1), Level 3 (55.2-72.4) and Level 4 (72.5-100). Higher levels means greater patient activation.
Measured: Baseline to 26 weeks
Change in Internal Stigma Score From Baseline to End of Intervention
Negative Image subscale of the HIV Stigma Scale will be used to detect internal stigma. The negative self-image subscale assesses an individual's negative feelings towards oneself due to HIV. The subscale uses a 4-point Likert scale that consists of items that ask respondents to rate their level of agreement (from strongly disagree to strongly agree) with statements related to self-worth. Total maximum score of the scale is 52 and minimum score is 13. Lower scores reflect better self-image.
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start11 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Rumah Sakit Universitas Indonesia, Jaringan Indonesia Positif
- Responsible party
- Principal investigator, Weiti Chen, RN, CNM, PhD, FAAN, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706634
- Sponsor's protocol ID
- IRB-25-1193
- Other IDs
- 1R01TW013110
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Disengagement Prevention in Treatment Naive Indonesians Living With HIV
- ClinicalTrials.gov ID
- NCT07706634
- Acronym / sponsor ID
- IRB-25-1193
- Conditions
- HIV, Indonesia, Engagement in HIV Care, Stigma
- Keywords
- HIV, Stigma reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Rumah Sakit Universitas Indonesia, Jaringan Indonesia Positif
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Jul 2026 (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.
This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status.
Detailed description
This project focuses on an innovative evidence-based stigma-reduction intervention that addresses HIV care engagement, which is key for reducing HIV transmission. This work is directly relevant to the U.S., including the Ending the HIV Epidemic (EHE) initiative, as stigma remains a key barrier to care engagement across variable populations. U.S. communities, including faith-based populations, need to strengthen retention across the HIV care continuum to reduce HIV transmission and eventually eradicate HIV infection from the U.S. However, there is a dearth of information related to strategies to reduce HIV stigma among Muslims who are living with HIV in the U.S., who are both widely distributed and in concentrations that make studies impossible to carry out over short time frames. As the world's largest Muslim-majority country, accounting for 13% of the global Muslim population, Indonesia provides a critical context for developing culturally grounded stigma-reduction interventions to improve HIV treatment engagement. In Asia, the population size of people living with HIV (PLH) in Indonesia is second only to that in India and China. According to recent estimates from UNAIDS, while there were an estimated 540,000 PLH in Indonesia in 2022, only 179,659 (33.27%) were reportedly on antiretroviral therapy (ART), 36,821 (6.82%) were regularly tested for viral load, and 33,395 (6.18%) achieved viral suppression. The majority of Indonesian PLHs are lost across the HIV care continuum, even after the government's Strategic Use of Antiretroviral Therapy program launched in 2013. The reasons for this failure to retain PLH in care include insufficient knowledge and limited accessibility and affordability of care, but the most prominent barrier is the fear of stigma. Stigma not only deters PLH from seeking care but also strains patient-provider relationships. Indeed, stigma is considered the greatest barrier to ending HIV in Indonesia whose cultural meanings surrounding HIV are rooted in the local "religious-familial" complex. The scientific premise is that HIV stigma remains rampant in Indonesia, where Islamic doctrine is prominent, with severe negative impacts on treatment engagement. This study addresses the critical need to increase treatment engagement among PLH and retain them in care by addressing the stigma surrounding HIV. Study aims are to adapt an evidence-based stigma reduction intervention and to test the feasibility, acceptability, and preliminary efficacy of the adapted intervention for stigma reduction and care engagement in a Muslim-dominant population. This study will provide transferable insights to inform stigma-reduction strategies and improve HIV care engagement in the U.S. context. The project's key innovations are culturally grounded modules informed by Islamic teachings on justice, compassion, and mindful prayer, while employing a nurse-led, low-intensity, four-session intervention model designed for scalability in resource-poor settings in the U.S. The project findings will advance the understanding of stigma reduction tools used to prevent leakage from the HIV care continuum and ultimately help protect the health of Americans.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stigma reduction | Experimental | Behavioral: Stigma reductionParticipants receive a stigma-reduction intervention that has been adapted for use in the target population. |
| Treatment as Usual | No intervention | –Participants receive typical services including care co-ordination and linkage to public health nurses in local communities. |
| Interview group | No intervention | –With the goal of culturally adapting an existing intervention for use among people living with HIV from Indonesia, in-depth interviews are conducted with Indonesians living with HIV. Participants in the interview group are not followed for outcomes or AEs. |
| Focus Group | No intervention | –Focus groups made up of Indonesians living with HIV are presented the adapted intervention. Feasibility, acceptability, and appropriateness are assessed that inform the final version of the adapted intervention for use in the target population. Participants in the focus group are not followed for outcomes or AEs. |
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
- Able to give informed consent
- Able to attend study visits
Key exclusion criteria (2 listed)
- Condition that prevents full participation in the study such as neurological disease, major depression or cardiovascular disease
- Unable to communicate
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 reductionThe study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population. | Behavioural | Stigma reduction |
Primary outcome
Change in Perceived Stigma Score From Baseline to End of Intervention
Time frame: Baseline to 26 weeks
The Perceived Stigma Scale (PSS) of the HIV Stigma Scale will be used to measure perceived stigma. Each item is measured using a 4-point Likert scale and the scale contains four factors: personalized stigma (18 items, subscore total 18-72), disclosure concerns (12 items, subscore total 12-48), negative self-image (9 items, subscore total 9-36), and concern with public attitudes about people with HIV (12 items, subscore total 12-48). Each factor is scored separately, with total score is computed by summing all 40 items, with a minimum total PSS score of 40 and a maximum possible score of 160. Raw PSS scores were transformed into Stigma scores 1-4. Higher scores reflect higher levels of perceived stigma.
Change in Adherence From Baseline to End of Intervention
Time frame: Baseline to 26 weeks
A one-item visual analog scale assesses 30-day HIV medication adherence, reported separately for each drug, along a continuum of "none of the doses" to "every dose." The maximum possible score for an individual drug item is 100 (representing 100% adherence, or "every dose"). Each drug is scored separately, with total score computed by summing all items, with a minimum total score of 0 (no medications taken) and a maximum possible score depending on the total number of medications in the participant's specific HIV regimen. Higher scores reflect higher levels of HIV medication adherence.
Level of Healthcare Engagement From Baseline to End of Intervention as Measured by Missed or Delayed Clinic Visits
Time frame: Baseline to 26 weeks
Proportions of missed or delayed clinic visits for HIV care will be calculated for each participant. Minimum scores are 0 (missed or delayed zero scheduled appointments) and maximum score is 1 (missed or delayed every single scheduled appointment). The score is derived by dividing the number of missed/delayed visits by the total number of scheduled visits for that specific participant. Higher scores indicate lower levels of HIV healthcare engagement.
Changes in Patient Activation from Baseline to End of Intervention
Time frame: Baseline to 26 weeks
The Patient Activation Measure-Short Form will be used to measure knowledge, skill, and confidence managing health. Statements are rated on a 4-point scale from "strongly disagree" to "strongly agree". Scores range from 0 to 100, which corresponds to one of four activation levels: Level 1 (0-47.0), Level 2 (47.1-55.1), Level 3 (55.2-72.4) and Level 4 (72.5-100). Higher levels means greater patient activation.
Change in Internal Stigma Score From Baseline to End of Intervention
Time frame: Baseline to 26 weeks
Negative Image subscale of the HIV Stigma Scale will be used to detect internal stigma. The negative self-image subscale assesses an individual's negative feelings towards oneself due to HIV. The subscale uses a 4-point Likert scale that consists of items that ask respondents to rate their level of agreement (from strongly disagree to strongly agree) with statements related to self-worth. Total maximum score of the scale is 52 and minimum score is 13. Lower scores reflect better self-image.
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data available upon reasonable request.
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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 Stigma reduction in people with HIV and Indonesia, run by University of California, Los Angeles at 1 site in Indonesia.
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: looking for participants now, as of the sponsor's last update on 17 Jul 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 Indonesia. 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 Wei-Ti Chen, RN, CNM, Ph.D., FAAN (310-206-8539, wchen@sonnet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stigma Score From Baseline to End of Intervention (time frame: Baseline to 26 weeks). The study lists 5 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 17 Jul 2026.