HIVTRACK IINCT01922206
Maternal HIV: Trial to Assist Disclosure to Children
A study testing TRACK Intervention in people with HIV, run by Georgia State University at 1 site in United States.
Trial summary
The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- What is being tested?
- TRACK Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother is HIV+
- ability of mother and child to speak and understand English or Spanish
- child is not HIV+
- Child is 6-14 years old
- Child is unaware of maternal HIV status
- child resides with mother
Who cannot join
- Mother does not consent
- Child does not assent
- Psychosis of mother or child
- Child diagnosed with depression
- child is developmentally delayed
- Recent or anticipated death in the family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children
The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot study of the intervention has recently been completed (R01 MH077493) and met its major aims. The basis for development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14) designed to longitudinally assess MLH and their children. Within that work, several studies were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for MLH and children could be improved by intervention. The pilot study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative disclosure theory. Results of the pilot trial indicate that those in the intervention group were six times more likely to disclose their HIV/AIDS status to their child than those in the control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more importantly, the intervention group's emotional functioning and their satisfaction improved significantly following the intervention, compared to the control group. Similarly, child mental health indicators among children of intervention MLH were significantly better than control group children at follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was conducted), which will include a high proportion of Latina families and a smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary consultant on the pilot trial conducts research), which will include a high proportion of Southern African-American families, as well as White families. MLH and their children (N = 440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the intervention or control. Aims are to:
- facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:
- increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV;
- reducing mothers' fears regarding disclosure and stigma;
- improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child;
- improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life);
- improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and
- improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child).
- Conditions
- HIV
- Being tested
- TRACK Intervention
- Keywords
- HIV, Maternal Disclosure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACK InterventionBehavioural
TRACK Intervention
3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
| Study group | Role | What they receive |
|---|---|---|
| Wait-list Control | No intervention | Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment. |
| TRACK Intervention | Experimental | 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child Receives: Behavioral: TRACK Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disclosure of Maternal HIV status to child
Measured: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
Secondary outcomes (1)
Child Mental Health Functioning (Composite measure)
Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire
Measured: 15- month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2017
- Study completionNov 2019
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Armistead, Georgia State University
- Investigators
- Lisa P Armistead, Ph.D., Principal investigator, Georgia State UniversityDebra Murphy, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922206
- Sponsor's protocol ID
- MH094233
- Other IDs
- 1R01MH094233
- Acronym
- TRACK II
- Status last verified
- Jan 2020
- First submitted
- 2 Aug 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data sharing protocols for the longitudinal data from 220 young children and 220 mothers will be in accordance with NIH Notice of Amendment to A-110, consistent with IRB-approved consent restrictions, and follow Inter-University Consortium for Political and Social Research guidelines for data preparation. Data will be stripped of identifiers and available under signed agreement for: (1) using data only for research; (2) securing date using appropriate technology; and (3) destroying or returning data after analyses. Notice of available data will be on both centers' websites, with data use restrictions.
Publications
Marelich WD, Ali B, Murphy DA, Schulte MT, Armistead L. Predictors of serostatus nondisclosure in mothers living with human immunodeficiency virus receiving a disclosure intervention: Analysis of a randomized clinical trial intervention arm. Health Psychol. 2024 Sep;43(9):663-672. doi: 10.1037/hea0001390. Epub 2024 Apr 25.
PubMed 38661649Schulte MT, Armistead L, Murphy DA, Marelich W. Multisite longitudinal efficacy trial of a disclosure intervention (TRACK) for HIV+ mothers. J Consult Clin Psychol. 2021 Feb;89(2):81-95. doi: 10.1037/ccp0000622.
PubMed 33705165
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children
- ClinicalTrials.gov ID
- NCT01922206
- Acronym / sponsor ID
- TRACK II / MH094233
- Conditions
- HIV
- Keywords
- HIV, Maternal Disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- Mar 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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 purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot study of the intervention has recently been completed (R01 MH077493) and met its major aims. The basis for development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14) designed to longitudinally assess MLH and their children. Within that work, several studies were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for MLH and children could be improved by intervention. The pilot study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative disclosure theory. Results of the pilot trial indicate that those in the intervention group were six times more likely to disclose their HIV/AIDS status to their child than those in the control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more importantly, the intervention group's emotional functioning and their satisfaction improved significantly following the intervention, compared to the control group. Similarly, child mental health indicators among children of intervention MLH were significantly better than control group children at follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was conducted), which will include a high proportion of Latina families and a smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary consultant on the pilot trial conducts research), which will include a high proportion of Southern African-American families, as well as White families. MLH and their children (N = 440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the intervention or control. Aims are to:
- facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:
- increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV;
- reducing mothers' fears regarding disclosure and stigma;
- improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child;
- improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life);
- improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and
- improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list Control | No intervention | –Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment. |
| TRACK Intervention | Experimental | Behavioral: TRACK Intervention3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Mother is HIV+
- ability of mother and child to speak and understand English or Spanish
- child is not HIV+
- Child is 6-14 years old
- Child is unaware of maternal HIV status
Key exclusion criteria (6 listed)
- Mother does not consent
- Child does not assent
- Psychosis of mother or child
- Child diagnosed with depression
- child is developmentally delayed
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 |
|---|---|---|
| TRACK InterventionTRACK Intervention 3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child | Behavioural | TRACK Intervention |
Primary outcome
Disclosure of Maternal HIV status to child
Time frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
1 secondary outcome
Child Mental Health Functioning (Composite measure)
Time frame: 15- month follow up
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 18 Jan 2020.
- Derived from this study: PubMed 38661649Marelich WD, Ali B, Murphy DA, Schulte MT, Armistead L. Predictors of serostatus nondisclosure in mothers living with human immunodeficiency virus receiving a disclosure intervention: Analysis of a randomized clinical trial intervention arm. Health Psychol. 2024 Sep;43(9):663-672. doi: 10.1037/hea0001390. Epub 2024 Apr 25.
- Derived from this study: PubMed 33705165Schulte MT, Armistead L, Murphy DA, Marelich W. Multisite longitudinal efficacy trial of a disclosure intervention (TRACK) for HIV+ mothers. J Consult Clin Psychol. 2021 Feb;89(2):81-95. doi: 10.1037/ccp0000622.
- Individual participant dataSharing planned: Yes. Data sharing protocols for the longitudinal data from 220 young children and 220 mothers will be in accordance with NIH Notice of Amendment to A-110, consistent with IRB-approved consent restrictions, and follow Inter-University Consortium for Political and Social Research guidelines for data preparation. Data will be stripped of identifiers and available under signed agreement for: (1) using data only for research; (2) securing date using appropriate technology; and (3) destroying or returning data after analyses. Notice of available data will be on both centers' websites, with data use restrictions.
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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.
Lisa P Armistead, Ph.D. principal investigator
Georgia State University
Debra Murphy, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRACK Intervention in people with HIV, run by Georgia State University 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 6 inclusion and 6 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 18 Jan 2020. 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. 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?
Disclosure of Maternal HIV status to child (time frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups). 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 NCT01922206, 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 18 Jan 2020.