Care Disengagement Prevention in PLWH in Indonesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Living with HIV

Able to give informed consent

Able to attend study visits

Disqualifiers

Condition that prevents full participation in the study such as neurological disease, major depression or cardiovascular disease

Unable to communicate

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stigma reduction

    Behavioral

    The study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population.

Treatment groups

110 Participants
are divided into 4 treatment groups
Group A: Stigma reductionExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Group C: Interview groupNo intervention 0 interventions
Group D: Focus GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 26 weeks
2

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.

Time frame
Baseline to 26 weeks
3

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.

Time frame
Baseline to 26 weeks
4

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.

Time frame
Baseline to 26 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, Los Angeles

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator

Rumah Sakit Universitas Indonesia

Collaborator

Jaringan Indonesia Positif

Collaborator