HIV/AIDSNCT05509959
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
A study testing Women SHINE in people with HIV/AIDS, run by University of California, San Diego at 1 site in United States.
Trial summary
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Women SHINE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 1 Sep 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cisgender female
- Diagnosis of HIV by a physician, healthcare provider, or community health worker
- Aged 18 years or older
- Speaking and reading English or Spanish
- Adulthood experiences of interpersonal violence
- Currently prescribed ART
Show all 9Show fewer
- Self-report of <90% past-month ART adherence
- Not currently participating in another adherence intervention
- Access to an internet browser
Who cannot join
- Unwillingness to participate in the intervention
- Transgender female
- No diagnosis of HIV by a physician, healthcare provider, or community health worker
- Aged less than 18 years
- Not speaking and reading English or Spanish
- Not currently prescribed ART
Show all 12Show fewer
- Self-report of >= 90% past-month ART adherence
- Currently participating in another adherence intervention
- No access to an internet browser
- Cognitive impairment limiting the ability to provide informed consent
- Experiencing only childhood experiences of interpersonal violence
- Inability to safely participate in the study based on secondary screener
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Regents of the Univ. of Calif., U.C. San Diego
La Jolla, California, 92093
Jamila K Stockman, PhD, 8588224652, jstockman@ucsd.edu
Jamila K Stockman, PhD
About this study
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).
Read the detailed description
In the US, women living with HIV/AIDS (WLHA) are less likely to be adherent to antiretroviral therapy (ART) and virally suppressed compared to men living with HIV/AIDS. Concurrently, WLHA experience high rates of interpersonal violence - physical, sexual, and/or psychological abuse in childhood or adulthood - which often results in trauma (e.g., post-traumatic stress disorder [PTSD]) and other adverse mental health, further contributing to ART non-adherence. Additionally, the confluence of syndemic or co-occurring adverse mental health, substance use, and socio-structural factors (e.g., HIV stigma, medical mistrust) further contribute to poor HIV outcomes. Social support through peer navigation and networks has been shown to counter these effects and improve HIV outcomes among WLHA. Likewise, psychoeducation addressing affective distress to improve mood and emotion management and relationship skills has been shown to reduce PTSD and depression. However, limited resources at HIV service agencies combined with socio-structural barriers (e.g., social isolation, lack of transportation) impede the potential effectiveness of in-person peer navigation. A scalable and sustainable solution is the use of technology in the form of web-based video interaction. Building on these promising pilot findings, investigators propose to conduct a randomized clinical trial of Women SHINE (new name) to improve ART adherence among WLHA affected by interpersonal violence in California, Arizona, and Nevada. Participants will be randomized to either: a) the intervention arm (n=180) where they will receive a 4-month program comprised of video-based peer navigation support via one-on-one sessions, 7 psychoeducation weekly support group sessions, and access to a static Women SHINE website with statewide resources for HIV care, interpersonal violence, trauma, mental health, and substance use; or b) the control arm (n=180) where they will receive a single group session on self-care and well-being, with access to the static Women SHINE website. Women will complete video-based survey assessments and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization. Compared to the control arm, investigators will determine if Women SHINE is associated with improvements in ART adherence (Aim 1) and PTSD symptoms and emotion regulation (Aim 2). Investigators will also examine individual (e.g., self-efficacy for coping, social support networks) and socio-structural (e.g., HIV stigma, medical mistrust) mechanisms of change in the efficacy of Women SHINE (Aim 3). If efficacious, investigators will conduct subsequent research to determine effective and feasible methods for intervention implementation nationwide to improve HIV outcomes among WLHA.
- Conditions
- HIV/AIDS
- Being tested
- Women SHINE, Control
- Keywords
- HIV Care Continuum, Psychoeducation
- 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.
Women SHINEBehavioural
Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.
ControlBehavioural
Single group session and access to website
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA. Receives: Behavioral: Control |
| Women SHINE | Experimental | Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention. Receives: Behavioral: Women SHINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ART Adherence
Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Measured: 4-, 8-, and 12-month post-randomization
Change in ART Adherence
Validated self-report measure of ART adherence (3 items)
Measured: 4-, 8-, and 12-month post-randomization
Change in PTSD Symptoms
Validated self-report measure of PTSD (9 items;PCL-5)
Measured: 4-, 8-, and 12-month post-randomization
Change in Emotion Regulation
Validated self-report measure of emotion regulation (16 items; DERS-16)
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of retention in HIV care
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of coping self-efficacy (26 items; CSE)
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of social support (8 items; mMOS-SS)
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of ancillary support utilization (26 items; adapted from CDC medical monitoring project), HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Measured: 4-, 8-, and 12-month post-randomization
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of medical mistrust (12 items; GBMMS)
Measured: 4-, 8-, and 12-month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start15 Nov 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jamila K. Stockman, University of California, San Diego
- Investigators
- Jamila K Stockman, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509959
- Sponsor's protocol ID
- 210509
- Other IDs
- R01MH125785
- Status last verified
- Oct 2025
- First submitted
- 26 Jul 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
- ClinicalTrials.gov ID
- NCT05509959
- Acronym / sponsor ID
- 210509
- Conditions
- HIV/AIDS
- Keywords
- HIV Care Continuum, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Aug 2022 (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.
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).
Detailed description
In the US, women living with HIV/AIDS (WLHA) are less likely to be adherent to antiretroviral therapy (ART) and virally suppressed compared to men living with HIV/AIDS. Concurrently, WLHA experience high rates of interpersonal violence - physical, sexual, and/or psychological abuse in childhood or adulthood - which often results in trauma (e.g., post-traumatic stress disorder [PTSD]) and other adverse mental health, further contributing to ART non-adherence. Additionally, the confluence of syndemic or co-occurring adverse mental health, substance use, and socio-structural factors (e.g., HIV stigma, medical mistrust) further contribute to poor HIV outcomes. Social support through peer navigation and networks has been shown to counter these effects and improve HIV outcomes among WLHA. Likewise, psychoeducation addressing affective distress to improve mood and emotion management and relationship skills has been shown to reduce PTSD and depression. However, limited resources at HIV service agencies combined with socio-structural barriers (e.g., social isolation, lack of transportation) impede the potential effectiveness of in-person peer navigation. A scalable and sustainable solution is the use of technology in the form of web-based video interaction. Building on these promising pilot findings, investigators propose to conduct a randomized clinical trial of Women SHINE (new name) to improve ART adherence among WLHA affected by interpersonal violence in California, Arizona, and Nevada. Participants will be randomized to either: a) the intervention arm (n=180) where they will receive a 4-month program comprised of video-based peer navigation support via one-on-one sessions, 7 psychoeducation weekly support group sessions, and access to a static Women SHINE website with statewide resources for HIV care, interpersonal violence, trauma, mental health, and substance use; or b) the control arm (n=180) where they will receive a single group session on self-care and well-being, with access to the static Women SHINE website. Women will complete video-based survey assessments and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization. Compared to the control arm, investigators will determine if Women SHINE is associated with improvements in ART adherence (Aim 1) and PTSD symptoms and emotion regulation (Aim 2). Investigators will also examine individual (e.g., self-efficacy for coping, social support networks) and socio-structural (e.g., HIV stigma, medical mistrust) mechanisms of change in the efficacy of Women SHINE (Aim 3). If efficacious, investigators will conduct subsequent research to determine effective and feasible methods for intervention implementation nationwide to improve HIV outcomes among WLHA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Behavioral: ControlWomen assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA. |
| Women SHINE | Experimental | Behavioral: Women SHINEWomen SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cisgender female
- Diagnosis of HIV by a physician, healthcare provider, or community health worker
- Aged 18 years or older
- Speaking and reading English or Spanish
- Adulthood experiences of interpersonal violence
Key exclusion criteria (12 listed)
- Unwillingness to participate in the intervention
- Transgender female
- No diagnosis of HIV by a physician, healthcare provider, or community health worker
- Aged less than 18 years
- Not speaking and reading English or Spanish
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 |
|---|---|---|
| Women SHINEMinimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions. | Behavioural | Women SHINE |
| ControlSingle group session and access to website | Behavioural | Control Arm |
Primary outcome
Change in ART Adherence
Time frame: 4-, 8-, and 12-month post-randomization
Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Change in ART Adherence
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of ART adherence (3 items)
Change in PTSD Symptoms
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of PTSD (9 items;PCL-5)
Change in Emotion Regulation
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of emotion regulation (16 items; DERS-16)
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of retention in HIV care
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of coping self-efficacy (26 items; CSE)
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of social support (8 items; mMOS-SS)
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of ancillary support utilization (26 items; adapted from CDC medical monitoring project), HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Change in Individual and Socio-Structural Mechanisms of Change
Time frame: 4-, 8-, and 12-month post-randomization
Validated self-report measure of medical mistrust (12 items; GBMMS)
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 20 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Jamila K Stockman, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women SHINE in people with HIV/AIDS, run by University of California, San Diego at 1 site in United States.
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 9 inclusion and 12 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 20 Oct 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 United States. 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. Some participants in this study may receive a placebo. 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 Cassandra Cyr, MPH ((858) 534-7979, clcyr@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ART Adherence (time frame: 4-, 8-, and 12-month post-randomization). The study lists 10 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 20 Oct 2025.