HIV ViremiaNCT05377463
Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression
A study testing Peer support to promote uptake and persistence of medication assisted treatment (MAT) and Behavioral Activation Treatment (BAT) to reduce depression in people with HIV Viremia, run by University of Texas, El Paso at 1 site in Mexico.
Trial summary
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression. The study design is a 2-to-the-2 factorial experiment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Viremia
- What is being tested?
- Peer support to promote uptake and persistence of medication assisted treatment (MAT) and Behavioral Activation Treatment (BAT) to reduce depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteMexico
- Study dates
- 10 May 2023to 31 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- be able to provide informed consent
- be eligible to receive free HIV care services in Mexico
- be HIV positive
- have injected drugs in the last 30 days
- not be on methadone replacement therapy
Show all 19Show fewer
- be willing to discuss MAT uptake with a peer
- sign a medical release form to have medical data abstracted
- agree to submit and describe locator information
- agree to return to follow-up visits
- able to communicate in Spanish
- screen positive for depression on the PHQ-2
- have no plans of moving outside the study area in the next 12-months
- meet one of the following:
- not currently in possession of ART or not taking ART but prescribed ART or
- sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
- sub-optimal retention in HIV care - never engaged or disengaged from HIV care as 2 or more missed clinic appointments in the last 9 months or
- no viral load test done in the past six months or
- self-reports a detectable viral load within the past 6 months
Who cannot join
- has not injected drugs in the last 30 days or do not have a verifiable opioid use disorder
- is not HIV positive
- is receiving methadone
- is unwilling to discuss methadone uptake with a peer
- does not screen positive for depression
- is not able to provide informed consent
Show all 10Show fewer
- does not speak Spanish
- has plans to move out of the city
- does not qualify to receive free HIV care services in Mexico
- has an appearance of psychological disturbance or severe cognitive impairment that could limit understanding of study procedures as determined by study staff
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Programa Compañeros
Ciudad Juárez, Chihuahua, 32330
Maria E Ramos, LSW, +526566113792, pcompa@prodigy.net.mx
Jocelyn Hernandez, LSW, +526566113792, johergo92@gmail.com
About this study
Official title: Optimizing a Bio-behavioral Intervention to Promote Viral Suppression Among HIV+ People Who Inject Drugs on the U.S.-Mexico Border
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression.
The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.
Read the detailed description
Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants complete a survey assessment at baseline, complete their assigned intervention components, and then return to complete follow-up assessment surveys at 3-, 6-,9-, and 12-months. The primary outcome is sustained viral suppression defined as viral load test results of <400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of the interventions. The secondary aims are to test mediators to explain component 1-2 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.
- Conditions
- HIV Viremia
- Being tested
- Peer support to promote uptake and persistence of medication assisted treatment (MAT), Behavioral Activation Treatment (BAT) to reduce depression, No Intervention Components
- Keywords
- HIV viral suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support to promote uptake and persistence of medication assisted treatment (MAT)Behavioural
Participants will be assigned to receive peer support to promote uptake of MAT and persistence. This component will consist of two informational sessions, a tailored recovery plan, and on-going support from a peer for the first 6 months.
Behavioral Activation Treatment (BAT) to reduce depressionBehavioural
Participants will be assigned to receive BAT treatment for depression. This component will consist of 8 sessions where participants will identify short and long-term goals, values, and the activities unrelated to substance use that were previously enjoyed or are likely to increase a feeling of well-being. This intervention component focuses on making a plan to troubleshoot barriers to re-engage in these activities. Sessions are delivered weekly. The content includes psycho-education about what depression is, the intervention rationale, and the activities and monitoring of activities, building social contracts to engage networks, and discussion of potential barriers to following through with activities.
No Intervention ComponentsBehavioural
Participants not assigned to components 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Component 1 | Experimental | 1) Peer-Support for Medication-Assisted Treatment Receives: Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT) |
| Condition 2: Component 2 | Experimental | 2) Behavioral Activation Therapy Receives: Behavioral: Behavioral Activation Treatment (BAT) to reduce depression |
| Condition 3: Components 1 and 2 | Experimental | Participants assigned to a combination of:
1. Peer-Support for Medication-Assisted Treatment
2. Behavioral Activation Therap Receives: Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT); Behavioral: Behavioral Activation Treatment (BAT) to reduce depression |
| Condition 4: No Components | Experimental | Participants not assigned to any of the 2 components. They are placed on a wait list and will receive components after the primary data collection period. Receives: Behavioral: No Intervention Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Viral Suppression
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of achieved viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Measured: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment
Viral Suppression at 9-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Measured: Viral load below or above 400 copiers per mL at the 9-month follow-up assessment
Viral Suppression at 12-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL.
Measured: Viral load below or above 400 copiers per mL at the 12-month follow-up assessment
Secondary outcomes (13)
Drug use
Will be measured through urine analysis and participants will self-report the frequency (yes vs no), quantity (how much typically consumed when using), and duration of use (how may days in the last 30 days did the participant use and how many times did the participant use yesterday) of various drugs in last 30 days.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Methadone uptake and persistence
Information about date of first dose, current dosage, and number of days on Methadone will be extracted from the medical record.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Drug use frequency and severity of withdrawal and cravings
Opioid Withdrawal Scale - This is a clinician administered scale that assesses the extent opiate withdrawal symptoms based on 11 symptoms (resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose, GI upset, tremors, yawning, anxiety or irritability, gooseflesh skin.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Clinician-assisted rating)
The Montgomery-Asberg Depression Rating Scale will be used, which is a 10-item scale and is clinician-assisted. interview participants and clinicians will rate their level of depression. Symptoms assessed include: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts
Measured: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Self-report)
The validated nine-item patient health questionnaire will be administered to participants to measure their level of depression. Participants will be asked to rate how many days of the last 2 weeks they have been bothered by having little interest or pleasure doing things, feeling down, feeling tired, having poor appetite, feeling bad about themselves, having trouble concentrating, moving or speaking slowly, and having thought of hurting themselves.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Behavioral activation for depression
The validated 25 item questionnaire will be administered to participants to assess changes in the behaviors in the past week that underlie their depression such as staying in bed too long, inability to do things that needed to be done, and being active and accomplishing goals.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Adherence to antiretroviral medication (ART)
Percent adherent to ART measure will be extracted from medical records
Measured: 3-,6-,9-, and 12-month follow-up assessments
Non-adherence to antiretroviral medication (ART)
Non-adherence will be measured as 4-day treatment interruptions (yes vs no) extracted from medical records.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Information, motivation, and behavioral skills to adhere to ART
Participants will answer the validated 30-item scale to assess psychological precursors of adherence including information (e.g., knowledge of how current HIV medications should be taken); Motivation (e.g., support from close significant others to take HIV medication); Behavioral skills (e.g, how easy it is to get HIV medications refills on time)
Measured: 3-,6-,9-, and 12-month follow-up assessments
Self-efficacy to adhere to ART
Participants will answer the validate 12-items scale assessing perceived self-efficacy to adhere to antiretroviral medication in the last 30 days. The scale asks about the level of confidence the participant has in keeping up with the treatment plan in spite of difficulties such as sided-effects and amid change in sleep and dietary habits and ability to integrate taking medications into the daily routine
Measured: 3-,6-,9-, and 12-month follow-up assessments
Retention in HIV care
Retention will be assessed by extracting from the medical record: appointments missed and appointments kept. A ratio will be computed using these two measures. At least one appointment kept in each three-month period will be an index of appointment constancy.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Logistical barriers to HIV care
Participants will be asked to indicate whether they have experienced common barriers to HIV care (yes/no) including availability of transportation, being able to access care, clinic hours of operation.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Perceived engagement in HIV care
Participants will answer the 10-item validated scale assessing perceived engagement in HIV care including level of trust in provider, feeling respected and understood by provider, degree of comfort in asking questions and interacting with provider, participant's perceived role in his medical care,.
Measured: 3-,6-,9-, and 12-month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 May 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV ViremiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 2 intervention components are: Component 1. Peer recovery coaching to promote uptake and persistence of medication assisted treatment in the form of methadone. Component 2. Behavioral activation therapy to reduce depression. Participants will be randomly assigned to receive a total of 0 or up to 2 components. There are 4 conditions because there are 4 possible combinations of the 2 components (e.g., Condition 1 = Delivery of 1 whereas Condition 3 = Delivery of 1 and 2). All participants will receive a standard of care package which will consist of referral and patient navigation to HIV treatment services, linkage to a peer support group, and harm reduction education and materials.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Centro de Integracion Juvenil, El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
- Responsible party
- Sponsor
- Investigators
- Julia Lechuga, Principal investigator, The University of Texas at El PasoJohn A Sauceda, Principal investigator, The University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377463
- Sponsor's protocol ID
- 1780619-1
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2022
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share a final modified quantitative dataset with the corresponding code book to validate all findings. The dataset will be modified to remove any potential identifiable information (such as date of birth). Interested parties will be asked to sign an agreement with MPIs Lechuga and Sauceda that specifies that the use of the data is for research purposes only. Furthermore, in order to have the data shared, each party must have: a) adequate systems in place to secure, encrypt and protect the data file to prevent the disclosure of identities, and b) a plan for destruction or returning the data files after all analyses have been completed. Prior to the sharing of data, approval from the requester's Institutional Review Board is required.
Publications
Sauceda JA, Lechuga J, Ramos ME, Puentes J, Ludwig-Barron N, Salazar J, Christopoulos KA, Johnson MO, Gomez D, Covarrubias R, Hernandez J, Montelongo D, Ortiz A, Rojas J, Ramos L, Avila I, Gwadz MV, Neilands TB. A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol. BMC Public Health. 2023 Feb 10;23(1):307. doi: 10.1186/s12889-023-15172-2.
PubMed 36765309
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Bio-behavioral Intervention to Promote Viral Suppression Among HIV+ People Who Inject Drugs on the U.S.-Mexico Border
- ClinicalTrials.gov ID
- NCT05377463
- Acronym / sponsor ID
- 1780619-1
- Conditions
- HIV Viremia
- Keywords
- HIV viral suppression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Centro de Integracion Juvenil, El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 May 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.
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression.
The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.
Detailed description
Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants complete a survey assessment at baseline, complete their assigned intervention components, and then return to complete follow-up assessment surveys at 3-, 6-,9-, and 12-months. The primary outcome is sustained viral suppression defined as viral load test results of <400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of the interventions. The secondary aims are to test mediators to explain component 1-2 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 2 intervention components are: Component 1. Peer recovery coaching to promote uptake and persistence of medication assisted treatment in the form of methadone. Component 2. Behavioral activation therapy to reduce depression. Participants will be randomly assigned to receive a total of 0 or up to 2 components. There are 4 conditions because there are 4 possible combinations of the 2 components (e.g., Condition 1 = Delivery of 1 whereas Condition 3 = Delivery of 1 and 2). All participants will receive a standard of care package which will consist of referral and patient navigation to HIV treatment services, linkage to a peer support group, and harm reduction education and materials.
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Component 1 | Experimental | Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT)1) Peer-Support for Medication-Assisted Treatment |
| Condition 2: Component 2 | Experimental | Behavioral: Behavioral Activation Treatment (BAT) to reduce depression2) Behavioral Activation Therapy |
| Condition 3: Components 1 and 2 | Experimental | Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT), Behavioral: Behavioral Activation Treatment (BAT) to reduce depressionParticipants assigned to a combination of: 1. Peer-Support for Medication-Assisted Treatment 2. Behavioral Activation Therap |
| Condition 4: No Components | Experimental | Behavioral: No Intervention ComponentsParticipants not assigned to any of the 2 components. They are placed on a wait list and will receive components after the primary data collection period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- be at least 18 years of age
- be able to provide informed consent
- be eligible to receive free HIV care services in Mexico
- be HIV positive
- have injected drugs in the last 30 days
Key exclusion criteria (10 listed)
- has not injected drugs in the last 30 days or do not have a verifiable opioid use disorder
- is not HIV positive
- is receiving methadone
- is unwilling to discuss methadone uptake with a peer
- does not screen positive for depression
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 |
|---|---|---|
| Peer support to promote uptake and persistence of medication assisted treatment (MAT)Participants will be assigned to receive peer support to promote uptake of MAT and persistence. This component will consist of two informational sessions, a tailored recovery plan, and on-going support from a peer for the first 6 months. | Behavioural | Condition 1: Component 1, Condition 3: Components 1 and 2 |
| Behavioral Activation Treatment (BAT) to reduce depressionParticipants will be assigned to receive BAT treatment for depression. This component will consist of 8 sessions where participants will identify short and long-term goals, values, and the activities unrelated to substance use that were previously enjoyed or are likely to increase a feeling of well-being. This intervention component focuses on making a plan to troubleshoot barriers to re-engage in these activities. Sessions are delivered weekly. The content includes psycho-education about what depression is, the intervention rationale, and the activities and monitoring of activities, building social contracts to engage networks, and discussion of potential barriers to following through with activities. | Behavioural | Condition 2: Component 2, Condition 3: Components 1 and 2 |
| No Intervention ComponentsParticipants not assigned to components 1 and 2 | Behavioural | Condition 4: No Components |
Primary outcome
Achievement of Viral Suppression
Time frame: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of achieved viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Viral Suppression at 9-month follow-up
Time frame: Viral load below or above 400 copiers per mL at the 9-month follow-up assessment
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Viral Suppression at 12-month follow-up
Time frame: Viral load below or above 400 copiers per mL at the 12-month follow-up assessment
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL.
13 secondary outcomes
Drug use
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Methadone uptake and persistence
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Drug use frequency and severity of withdrawal and cravings
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Clinician-assisted rating)
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Depressive Symptoms (Self-report)
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Behavioral activation for depression
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Adherence to antiretroviral medication (ART)
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Non-adherence to antiretroviral medication (ART)
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Information, motivation, and behavioral skills to adhere to ART
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Self-efficacy to adhere to ART
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Retention in HIV care
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Logistical barriers to HIV care
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Perceived engagement in HIV care
Time frame: 3-,6-,9-, and 12-month follow-up assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Derived from this study: PubMed 36765309Sauceda JA, Lechuga J, Ramos ME, Puentes J, Ludwig-Barron N, Salazar J, Christopoulos KA, Johnson MO, Gomez D, Covarrubias R, Hernandez J, Montelongo D, Ortiz A, Rojas J, Ramos L, Avila I, Gwadz MV, Neilands TB. A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol. BMC Public Health. 2023 Feb 10;23(1):307. doi: 10.1186/s12889-023-15172-2.
- Individual participant dataSharing planned: Yes. We will share a final modified quantitative dataset with the corresponding code book to validate all findings. The dataset will be modified to remove any potential identifiable information (such as date of birth). Interested parties will be asked to sign an agreement with MPIs Lechuga and Sauceda that specifies that the use of the data is for research purposes only. Furthermore, in order to have the data shared, each party must have: a) adequate systems in place to secure, encrypt and protect the data file to prevent the disclosure of identities, and b) a plan for destruction or returning the data files after all analyses have been completed. Prior to the sharing of data, approval from the requester's Institutional Review Board is required.
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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.
Julia Lechuga principal investigator
The University of Texas at El Paso
John A Sauceda principal investigator
The University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support to promote uptake and persistence of medication assisted treatment (MAT) and Behavioral Activation Treatment (BAT) to reduce depression in people with HIV Viremia, run by University of Texas, El Paso at 1 site in Mexico.
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 19 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Lechuga, PhD (915-747-7221, julialec@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Viral Suppression (time frame: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment). The study lists 3 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 NCT05377463, which also lists 1 linked publication.
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 3 Sep 2024.