HIVNCT05784714
NOLA GEM: Feasibility and Acceptability of an MHealth Intervention for Violence-affected PLWH
A study testing NOLA GEM in people with HIV and Mental Health, run by Tulane University at 4 sites in United States.
Trial summary
The objective of the proposed research is to conduct formative work to develop, pilot and refine a smartphone delivered intervention for violence affected people living with HIV utilizing a novel spatial-temporal methodology, geographical ecological momentary assessment (GEMA), to first identify the activity spaces… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Mental Health, Substance Use
- What is being tested?
- NOLA GEM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jul 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a reported HIV infection and being on ART.
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Access Health Louisiana
New Orleans, Louisiana, 70112
Women With A Vision
New Orleans, Louisiana, 70113
CrescentCare
New Orleans, Louisiana, 70117
Institute of Women & Ethnic Studies
New Orleans, Louisiana, 70122
About this study
Official title: Development of a Geographical Momentary Assessment Informed Trauma Intervention to Improve ART Adherence and Viral Suppression in Violence-Affected Persons Living with HIV
The objective of the proposed research is to conduct formative work to develop, pilot and refine a smartphone delivered intervention for violence affected people living with HIV utilizing a novel spatial-temporal methodology, geographical ecological momentary assessment (GEMA), to first identify the activity spaces and daily psychosocial experiences (mental health symptoms, substance use, self-efficacy, coping) impacting adherence and viral suppression, and apply them to intervention. Guided by an ecological perspective, the investigators will adapt Living in the Face of Trauma to a mobile platform with GEMA informed intervention targets. The resulting app shall be referred to as NOLA GEM. Our long-term goal is delivering accessible interventions informed by daily experiences that affect health for PLWH. The investigators will test feasibility, acceptability and preliminary efficacy of the GEMA-informed NOLA GEM app against GEMA alone on adherence and care, and secondary outcomes of mental health and substance use.
- Conditions
- HIV, Mental Health, Substance Use
- Being tested
- NOLA GEM
- Keywords
- Adherence, mHealth, Care engagement
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOLA GEMBehavioural
This is a mobile application that has 6 psychoeducational sessions and related skills, local resources, and a way for participants to track their progress. Further information is in the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will include daily diary assessment and GPS phone tracking, access to psychoeducational modules, skills practice, and tools to help with coping and stress reduction. Enhancements include geofencing alerts for risky environments; progress tracking and feedback reports; self-initiated tool engagement (e.g. push button to engage in coping exercise), robust JITAI programming that recommends skills for participants to use in the moment based on daily diary responses, positive mood building exercises, and support. Receives: Behavioral: NOLA GEM |
| GEMA | No intervention | This arm will include daily diary and phone tracking. Participants in this arm will also respond to daily diary assessments twice daily but will not receive the psychoeducation interactive components such as tracking and feedback, alerts, or capacity to send alerts that connect them to tools. This arm will have access to resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Self report taking all HIV-related medication and treatment in past 30 days
Measured: 30 day post-assessment
Viral Load
Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Measured: 90 days post assessment
Care Engagement
Self report % of missed appointments in past 90 days
Measured: 90 days post assessment
Care Engagement
HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Measured: 30 days post assessment
Acceptability of intervention
User Experience Questionnaire-Short Form
Measured: 30 day post-assessment
Acceptability of intervention
Net Promotor Score; 0-10; higher score means more likely to recommend to a friend
Measured: 30 day post-assessment
Feasibility of intervention
App usage paradata
Measured: 30 day post-assessment
Feasibility of intervention
Participation rates
Measured: 30 day post-assessment
Secondary outcomes (8)
PTSD
PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology
Measured: 30 day post-assessment
Depression, anxiety
Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression
Measured: 30 day post-assessment
Stress
Study generated daily stressors severity checklist
Measured: 30 day post-assessment
Stress
Perceived Stress Scale 4; 0-16; higher score is correlated to more stress
Measured: 30 day post-assessment
Coping
Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles
Measured: 30 day post-assessment
Coping
adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy
Measured: 30 day post-assessment
Substance use
Adapted Addiction Severity Index
Measured: 30 day post-assessment
Substance use
Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking
Measured: 30 day post-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start14 Jul 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784714
- Sponsor's protocol ID
- R34AA02896m
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gasik RE, Skeen SJ, Tokarz S, Theall KP, Clum GA. Outcomes of a Pilot Mobile App Just-in-Time-Adaptive-Intervention Supporting Coping Skills in Trauma Affected People with HIV. AIDS Behav. 2026 Jul;30(7):2069-2081. doi: 10.1007/s10461-026-05032-6. Epub 2026 Jan 23.
PubMed 41575709Skeen SJ, Tokarz S, Gasik RE, Solano CM, Smith EA, Sagoe MB, Hudson LV, Steele K, Theall KP, Clum GA. A Trauma-Informed, Geospatially Aware, Just-in-Time Adaptive mHealth Intervention to Support Effective Coping Skills Among People Living With HIV in New Orleans: Development and Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 24;12:e47151. doi: 10.2196/47151.
PubMed 37874637
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Geographical Momentary Assessment Informed Trauma Intervention to Improve ART Adherence and Viral Suppression in Violence-Affected Persons Living with HIV
- ClinicalTrials.gov ID
- NCT05784714
- Acronym / sponsor ID
- R34AA02896m
- Conditions
- HIV, Mental Health, Substance Use
- Keywords
- Adherence, mHealth, Care engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 27 Mar 2023 (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.
The objective of the proposed research is to conduct formative work to develop, pilot and refine a smartphone delivered intervention for violence affected people living with HIV utilizing a novel spatial-temporal methodology, geographical ecological momentary assessment (GEMA), to first identify the activity spaces and daily psychosocial experiences (mental health symptoms, substance use, self-efficacy, coping) impacting adherence and viral suppression, and apply them to intervention. Guided by an ecological perspective, the investigators will adapt Living in the Face of Trauma to a mobile platform with GEMA informed intervention targets. The resulting app shall be referred to as NOLA GEM. Our long-term goal is delivering accessible interventions informed by daily experiences that affect health for PLWH. The investigators will test feasibility, acceptability and preliminary efficacy of the GEMA-informed NOLA GEM app against GEMA alone on adherence and care, and secondary outcomes of mental health and substance use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: NOLA GEMThis arm will include daily diary assessment and GPS phone tracking, access to psychoeducational modules, skills practice, and tools to help with coping and stress reduction. Enhancements include geofencing alerts for risky environments; progress tracking and feedback reports; self-initiated tool engagement (e.g. push button to engage in coping exercise), robust JITAI programming that recommends skills for participants to use in the moment based on daily diary responses, positive mood building exercises, and support. |
| GEMA | No intervention | –This arm will include daily diary and phone tracking. Participants in this arm will also respond to daily diary assessments twice daily but will not receive the psychoeducation interactive components such as tracking and feedback, alerts, or capacity to send alerts that connect them to tools. This arm will have access to resources. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having a reported HIV infection and being on ART.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NOLA GEMThis is a mobile application that has 6 psychoeducational sessions and related skills, local resources, and a way for participants to track their progress. Further information is in the arm descriptions. | Behavioural | Intervention |
Primary outcome
Adherence
Time frame: 30 day post-assessment
Self report taking all HIV-related medication and treatment in past 30 days
Viral Load
Time frame: 90 days post assessment
Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Care Engagement
Time frame: 90 days post assessment
Self report % of missed appointments in past 90 days
Care Engagement
Time frame: 30 days post assessment
HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Acceptability of intervention
Time frame: 30 day post-assessment
User Experience Questionnaire-Short Form
Acceptability of intervention
Time frame: 30 day post-assessment
Net Promotor Score; 0-10; higher score means more likely to recommend to a friend
Feasibility of intervention
Time frame: 30 day post-assessment
App usage paradata
Feasibility of intervention
Time frame: 30 day post-assessment
Participation rates
8 secondary outcomes
PTSD
Time frame: 30 day post-assessment
Depression, anxiety
Time frame: 30 day post-assessment
Stress
Time frame: 30 day post-assessment
Stress
Time frame: 30 day post-assessment
Coping
Time frame: 30 day post-assessment
Coping
Time frame: 30 day post-assessment
Substance use
Time frame: 30 day post-assessment
Substance use
Time frame: 30 day post-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41575709Gasik RE, Skeen SJ, Tokarz S, Theall KP, Clum GA. Outcomes of a Pilot Mobile App Just-in-Time-Adaptive-Intervention Supporting Coping Skills in Trauma Affected People with HIV. AIDS Behav. 2026 Jul;30(7):2069-2081. doi: 10.1007/s10461-026-05032-6. Epub 2026 Jan 23.
- Derived from this study: PubMed 37874637Skeen SJ, Tokarz S, Gasik RE, Solano CM, Smith EA, Sagoe MB, Hudson LV, Steele K, Theall KP, Clum GA. A Trauma-Informed, Geospatially Aware, Just-in-Time Adaptive mHealth Intervention to Support Effective Coping Skills Among People Living With HIV in New Orleans: Development and Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 24;12:e47151. doi: 10.2196/47151.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOLA GEM in people with HIV and Mental Health, run by Tulane University at 4 sites 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 1 inclusion and 1 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence (time frame: 30 day post-assessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784714, which also lists 2 linked publications.
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 Dec 2024.