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Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Primary Purpose

HIV Viremia

Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Peer support to promote uptake and persistence of medication assisted treatment (MAT)
Behavioral Activation Treatment (BAT) to reduce depression
Patient Navigation to promote linkage and engagement in HIV care
Life Steps educational and skill building session to promote adherence to HIV medication
Sponsored by
University of Texas, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Viremia focused on measuring HIV viral suppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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:

    1. not currently in possession of ART or not taking ART but prescribed ART or
    2. sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
    3. 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
    4. no viral load test done in the past six months or
    5. self-reports a detectable viral load within the past 6 months

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Programa Compañeros

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1: Components 1, 2, 3 and 4

Condition 2: Components 1, 2, 3

Condition 3: Components 1, 2 and 4

Condition 4: Components 1 and 2

Condition 5: Component 1, 3, and 4

Condition 6: Component 1 and 3

Condition 7: Component 1 and 4

Condition 8: Component 1

Condition 9: Components 2, 3, and 4

Condition 10: Components 2 and 3

Condition 11: Component 2 and 4

Condition 12: Component 2

Condition 13: Component 3 and 4

Condition 14: Component 3

Condition 15: Component 4

Condition 16: No Components

Arm Description

Participants will be assigned to receive all of the four intervention programs: Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy Patient Navigation for HIV Care Life Steps Program for Medication Adherence

Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy Patient Navigation for HIV Care

Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy 4) Life Steps Program for Medication Adherence

Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy

1) Peer-Support for Medication-Assisted Treatment 3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence

1) Peer-Support for Medication-Assisted Treatment 3) Patient Navigation for HIV Care

1) Peer-Support for Medication-Assisted Treatment 4) Life Steps Program for Medication Adherence

1) Peer-Support for Medication-Assisted Treatment

2) Behavioral Activation Therapy 3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence

2) Behavioral Activation Therapy 3) Patient Navigation for HIV Care

2) Behavioral Activation Therapy 4) Life Steps Program for Medication Adherence

2) Behavioral Activation Therapy

3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence

3) Patient Navigation for HIV Care

4) Life Steps Program for Medication Adherence

Participants not assigned to any of the 4 components. They are placed on a wait list and will receive components after the primary data collection period.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
Adherence to antiretroviral medication (ART)
Percent adherent to ART measure will be extracted from medical records
Non-adherence to antiretroviral medication (ART)
Non-adherence will be measured as 4-day treatment interruptions (yes vs no) extracted from medical records.
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)
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
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.
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.
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,.

Full Information

First Posted
April 11, 2022
Last Updated
May 10, 2023
Sponsor
University of Texas, El Paso
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
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1. Study Identification

Unique Protocol Identification Number
NCT05377463
Brief Title
Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression
Official Title
Optimizing a Bio-behavioral Intervention to Promote Viral Suppression Among HIV+ People Who Inject Drugs on the U.S.-Mexico Border
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas, El Paso
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will test four behavioral intervention components to identify the combination of the four components that best supports people who inject drugs to achieve and sustain HIV viral load suppression. The study design is a 2-to-the-4 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 4 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, 2) behavioral activation therapy for depression (BAT), 3) Life-Steps Program for medication adherence, and 4) patient navigation for HIV care. Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 16 conditions. Each condition represents a possible combination of the 4 components above.
Detailed Description
Participants will be randomly assigned to one of 16 experimental conditions. Each condition will represents every possible combination of 4 components (e.g., 1-4, 2-4, 4 only). 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 1-4 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Viremia
Keywords
HIV viral suppression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 4 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. Component 3. Patient navigation to promote linkage and engagement in care. Component 4. Life steps educational and skill building intervention to promote medication adherence. Participants will be randomly assigned to receive a total of 0 or up to 4 components. There are 16 conditions because there are 16 possible combinations of the 4 components (e.g., Condition 1 = Delivery of 1, 2, 3, and 4 whereas Condition 4 = Delivery of 1 and 2 only). All participants will receive a standard of care package which will consist of referral to HIV treatment services and linkage to a peer support group, and harm reduction education and materials.
Masking
Outcomes Assessor
Masking Description
The outcome assessors will be blind to the experimental condition that the participant was assigned to.
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Condition 1: Components 1, 2, 3 and 4
Arm Type
Experimental
Arm Description
Participants will be assigned to receive all of the four intervention programs: Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy Patient Navigation for HIV Care Life Steps Program for Medication Adherence
Arm Title
Condition 2: Components 1, 2, 3
Arm Type
Experimental
Arm Description
Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy Patient Navigation for HIV Care
Arm Title
Condition 3: Components 1, 2 and 4
Arm Type
Experimental
Arm Description
Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy 4) Life Steps Program for Medication Adherence
Arm Title
Condition 4: Components 1 and 2
Arm Type
Experimental
Arm Description
Peer-Support for Medication-Assisted Treatment Behavioral Activation Therapy
Arm Title
Condition 5: Component 1, 3, and 4
Arm Type
Experimental
Arm Description
1) Peer-Support for Medication-Assisted Treatment 3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence
Arm Title
Condition 6: Component 1 and 3
Arm Type
Experimental
Arm Description
1) Peer-Support for Medication-Assisted Treatment 3) Patient Navigation for HIV Care
Arm Title
Condition 7: Component 1 and 4
Arm Type
Experimental
Arm Description
1) Peer-Support for Medication-Assisted Treatment 4) Life Steps Program for Medication Adherence
Arm Title
Condition 8: Component 1
Arm Type
Experimental
Arm Description
1) Peer-Support for Medication-Assisted Treatment
Arm Title
Condition 9: Components 2, 3, and 4
Arm Type
Experimental
Arm Description
2) Behavioral Activation Therapy 3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence
Arm Title
Condition 10: Components 2 and 3
Arm Type
Experimental
Arm Description
2) Behavioral Activation Therapy 3) Patient Navigation for HIV Care
Arm Title
Condition 11: Component 2 and 4
Arm Type
Experimental
Arm Description
2) Behavioral Activation Therapy 4) Life Steps Program for Medication Adherence
Arm Title
Condition 12: Component 2
Arm Type
Experimental
Arm Description
2) Behavioral Activation Therapy
Arm Title
Condition 13: Component 3 and 4
Arm Type
Experimental
Arm Description
3) Patient Navigation for HIV Care 4) Life Steps Program for Medication Adherence
Arm Title
Condition 14: Component 3
Arm Type
Experimental
Arm Description
3) Patient Navigation for HIV Care
Arm Title
Condition 15: Component 4
Arm Type
Experimental
Arm Description
4) Life Steps Program for Medication Adherence
Arm Title
Condition 16: No Components
Arm Type
Experimental
Arm Description
Participants not assigned to any of the 4 components. They are placed on a wait list and will receive components after the primary data collection period.
Intervention Type
Behavioral
Intervention Name(s)
Peer support to promote uptake and persistence of medication assisted treatment (MAT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Treatment (BAT) to reduce depression
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation to promote linkage and engagement in HIV care
Intervention Description
Participants will be assigned to receive patient navigation services. A patient navigator will provide information about the process of obtaining HIV care and provide instrumental support to access care as needed for six months. The navigator will assist with obtaining government sponsored insurance if the participant does not have employer sponsored insurance, including processing needed documents, monetary resources, transportation and clerical support to obtain required documents, such as state ID and birth certificates. Navigators will meet with participants to go over what to expect during their clinic appointment and explain in lay terms medical terminology likely to be discussed by providers to facilitate patient-provider interaction. Other instrumental support provided will be scheduling appointments, providing clean clothing, a place to shower, and transportation to attend medical appointments.
Intervention Type
Behavioral
Intervention Name(s)
Life Steps educational and skill building session to promote adherence to HIV medication
Intervention Description
Participants assigned to this component will participate in a single session that includes one follow-up phone-call or visit. Participants will be exposed to cognitive-behavioral techniques and will learn about the importance of HIV treatment and the strategies and skills needed to take HIV treatment as prescribed. The session consists of strategies for problem solving transportation barriers, skills to improve communication with providers, strategies for dealing with side-effects, reminder cues, and managing lapses.
Primary Outcome Measure Information:
Title
Achievement of Viral Suppression
Description
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.
Time Frame
Viral load below or above 400 copiers per mL at the 6-month follow-up assessment
Title
Viral Suppression at 9-month follow-up
Description
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.
Time Frame
Viral load below or above 400 copiers per mL at the 9-month follow-up assessment
Title
Viral Suppression at 12-month follow-up
Description
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.
Time Frame
Viral load below or above 400 copiers per mL at the 12-month follow-up assessment
Secondary Outcome Measure Information:
Title
Drug use
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Methadone uptake and persistence
Description
Information about date of first dose, current dosage, and number of days on Methadone will be extracted from the medical record.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Drug use frequency and severity of withdrawal and cravings
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Depressive Symptoms (Clinician-assisted rating)
Description
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
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Depressive Symptoms (Self-report)
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Behavioral activation for depression
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Adherence to antiretroviral medication (ART)
Description
Percent adherent to ART measure will be extracted from medical records
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Non-adherence to antiretroviral medication (ART)
Description
Non-adherence will be measured as 4-day treatment interruptions (yes vs no) extracted from medical records.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Information, motivation, and behavioral skills to adhere to ART
Description
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)
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Self-efficacy to adhere to ART
Description
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
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Retention in HIV care
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Logistical barriers to HIV care
Description
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.
Time Frame
3-,6-,9-, and 12-month follow-up assessments
Title
Perceived engagement in HIV care
Description
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,.
Time Frame
3-,6-,9-, and 12-month follow-up assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Lechuga
Organizational Affiliation
The University of Texas at El Paso
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John A Sauceda
Organizational Affiliation
The University of California San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Programa Compañeros
City
Ciudad Juárez
State/Province
Chihuahua
ZIP/Postal Code
32330
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be made available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
IPD Sharing Access Criteria
Directions for requesting the dataset will be available at the official study website, which is to be developed. This information will be found in all publications and conference abstract presentations. An individual participant data statement noting steps to access the data is to be developed.

Learn more about this trial

Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

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