Health BehaviorNCT02888288
Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
A study testing Mental Health Intervention in people with Health Behavior and HIV, run by Duke University at 1 site in Tanzania.
Trial summary
The purpose of this study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Health Behavior, HIV, Mental Health
- What is being tested?
- Mental Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2016to 28 Aug 2020
- 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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
- if > or =l to 18 years, able to understand the project and provide written, informed consent
- if < 18 years, a parent or guardian must provide written permission and participant must be able to assent
- all adolescents must also commit to attending 10 weekly CBT (SYV) sessions and 2 individual sessions.
Who cannot join
- Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents as compared to youth receiving treatment as usual. Mental health intervention sessions will take place three times a month for approximately four months in groups of eight to ten youth based on age and sex. Caregivers will attend two sessions to support the youth and provide the guardian perspective on caring for HIV-positive adolescents. The investigator hypothesizes the mental health intervention will be acceptable, feasible, and will improve mental health and ART adherence among participating youth and this improvement will be sustained over time.
Read the detailed description
The study will enroll up to approximately 130 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to approximately eight to ten persons per group, based on age and sex. Groups will be matched in pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before the start of mental health intervention for each wave. Individuals will be randomized at this time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization will occur by a coin flip for two individuals based on alphabetical order: heads will be intervention group (I) and tails the standard of care group (SOC).
This feasibility study is longitudinal with up to 24 month follow-up after intervention. Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be obtained by blinded interviewers using a structured survey to inquire about mental health symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample, and HIV-1 viral load from a blood sample and will be collected by the same research assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3) post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6) 24-months post-intervention.
- Conditions
- Health Behavior, HIV, Mental Health
- Being tested
- Mental Health Intervention, Standard of Care
- Keywords
- adolescent, adolescence, HIV/AIDS, mental health, cognitive behavioral therapy
- Medical subject headings
- Health Behavior, Psychological Well-Being, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health InterventionBehavioural
Includes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions.
Standard of CareBehavioural
Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Intervention | Experimental | This arm was designed based on mental health needs of HIV-infected youth in Tanzania. It incorporates principles of cognitive behavioral therapy, interpersonal psychotherapy, and motivational interviewing built into 10 group sessions, approximately 90 minutes each (2 sessions with caregiver participation) and 2 individual sessions. Groups are age and gender matched and facilitated by lay counselors with a mix of lived experience and prior mental health research experience. Receives: Behavioral: Mental Health Intervention |
| Standard of Care | Active comparator | This arm includes standard medical care and adherence counseling with routine education prior to the start of the HIV youth clinic from which participants are recruited. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant attendance
Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.
Measured: weekly for 16 weeks during each intervention wave (over 2 years)
Caregiver participation as measured by questionnaire
Record willingness of caregivers to participate (if unwilling, why not) and attendance.
Measured: during 2 caregiver sessions
Caregiver participation as measured by attendance sheet
Measured: during 2 caregiver sessions
Fidelity as measured by weekly supervisor meeting
Measured: weekly for 16 weeks during the intervention wave (over 2 years)
Fidelity as measured by fidelity checklists
Measured: weekly for 16 weeks during the intervention wave (over 2 years)
Secondary outcomes (9)
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the PHQ-9, between the intervention group versus SOC.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the SDQ, between the intervention group versus SOC.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the UCLA PTSD-RI, between the intervention group versus SOC.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in ART adherence
Compare the change in self-report adherence between the intervention group versus SOC.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in virologic outcomes
Describe the proportion of youth with viral suppression (HIV-1 RNA < 400 copies/ml) in the intervention group and SOC.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Compare method of adherence measurement
Compare self-report ART adherence with drug level concentration of hair samples.
Measured: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in mental health (individual)
Compare the change in standard deviation of mental health symptoms on the PHQ-9, SDQ, UCLA PTSD-RI at the individual level.
Measured: baseline to post-intervention, 6-, 12-,18- and 24-months
Change in adherence (individual)
Compare the change in self-reported adherence and antiretroviral drug concentration in hair.
Measured: baseline to post-intervention, 6-, 12-, and 24-months
Change in HIV viral load (individual)
Compare the change in HIV viral load.
Measured: baseline to post-intervention, 6-, 12-, and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Sponsor
- Investigators
- Dorothy E Dow, MD, MSc-GH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888288
- Sponsor's protocol ID
- Pro00069892
- Status last verified
- Oct 2022
- First submitted
- 9 Aug 2016
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dow DE, Turner EL, Shayo AM, Mmbaga B, Cunningham CK, O'Donnell K. Evaluating mental health difficulties and associated outcomes among HIV-positive adolescents in Tanzania. AIDS Care. 2016 Jul;28(7):825-33. doi: 10.1080/09540121.2016.1139043. Epub 2016 Feb 3.
PubMed 26837437Ramaiya MK, Sullivan KA, O' Donnell K, Cunningham CK, Shayo AM, Mmbaga BT, Dow DE. A Qualitative Exploration of the Mental Health and Psychosocial Contexts of HIV-Positive Adolescents in Tanzania. PLoS One. 2016 Nov 16;11(11):e0165936. doi: 10.1371/journal.pone.0165936. eCollection 2016.
PubMed 27851797Gichane MW, Sullivan KA, Shayo AM, Mmbaga BT, O' Donnell K, Cunningham CK, Dow DE. Caregiver role in HIV medication adherence among HIV-infected orphans in Tanzania. AIDS Care. 2018 Jun;30(6):701-705. doi: 10.1080/09540121.2017.1391986. Epub 2017 Oct 23.
PubMed 29058461Dow DE, Mmbaga BT, Gallis JA, Turner EL, Gandhi M, Cunningham CK, O'Donnell KE. A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial. BMC Public Health. 2020 Sep 4;20(1):1358. doi: 10.1186/s12889-020-09380-3.
PubMed 32887558
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
- ClinicalTrials.gov ID
- NCT02888288
- Acronym / sponsor ID
- Pro00069892
- Conditions
- Health Behavior, HIV, Mental Health
- Keywords
- adolescent, adolescence, HIV/AIDS, mental health, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- Jul 2016 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 5 Sep 2016 (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 study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents as compared to youth receiving treatment as usual. Mental health intervention sessions will take place three times a month for approximately four months in groups of eight to ten youth based on age and sex. Caregivers will attend two sessions to support the youth and provide the guardian perspective on caring for HIV-positive adolescents. The investigator hypothesizes the mental health intervention will be acceptable, feasible, and will improve mental health and ART adherence among participating youth and this improvement will be sustained over time.
Detailed description
The study will enroll up to approximately 130 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to approximately eight to ten persons per group, based on age and sex. Groups will be matched in pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before the start of mental health intervention for each wave. Individuals will be randomized at this time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization will occur by a coin flip for two individuals based on alphabetical order: heads will be intervention group (I) and tails the standard of care group (SOC).
This feasibility study is longitudinal with up to 24 month follow-up after intervention. Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be obtained by blinded interviewers using a structured survey to inquire about mental health symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample, and HIV-1 viral load from a blood sample and will be collected by the same research assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3) post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6) 24-months post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health Intervention | Experimental | Behavioral: Mental Health InterventionThis arm was designed based on mental health needs of HIV-infected youth in Tanzania. It incorporates principles of cognitive behavioral therapy, interpersonal psychotherapy, and motivational interviewing built into 10 group sessions, approximately 90 minutes each (2 sessions with caregiver participation) and 2 individual sessions. Groups are age and gender matched and facilitated by lay counselors with a mix of lived experience and prior mental health research experience. |
| Standard of Care | Active comparator | Behavioral: Standard of CareThis arm includes standard medical care and adherence counseling with routine education prior to the start of the HIV youth clinic from which participants are recruited. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
- if > or =l to 18 years, able to understand the project and provide written, informed consent
- if < 18 years, a parent or guardian must provide written permission and participant must be able to assent
- all adolescents must also commit to attending 10 weekly CBT (SYV) sessions and 2 individual sessions.
Key exclusion criteria (1 listed)
- Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
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 |
|---|---|---|
| Mental Health InterventionIncludes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions. | Behavioural | Mental Health Intervention |
| Standard of CareStandard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic. | Behavioural | Standard of Care |
Primary outcome
Participant attendance
Time frame: weekly for 16 weeks during each intervention wave (over 2 years)
Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.
Caregiver participation as measured by questionnaire
Time frame: during 2 caregiver sessions
Record willingness of caregivers to participate (if unwilling, why not) and attendance.
Caregiver participation as measured by attendance sheet
Time frame: during 2 caregiver sessions
Fidelity as measured by weekly supervisor meeting
Time frame: weekly for 16 weeks during the intervention wave (over 2 years)
Fidelity as measured by fidelity checklists
Time frame: weekly for 16 weeks during the intervention wave (over 2 years)
9 secondary outcomes
Change in Mental Health
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in ART adherence
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in virologic outcomes
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Compare method of adherence measurement
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in mental health (individual)
Time frame: baseline to post-intervention, 6-, 12-,18- and 24-months
Change in adherence (individual)
Time frame: baseline to post-intervention, 6-, 12-, and 24-months
Change in HIV viral load (individual)
Time frame: baseline to post-intervention, 6-, 12-, and 24-months
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 7 Oct 2022.
- Background: PubMed 26837437Dow DE, Turner EL, Shayo AM, Mmbaga B, Cunningham CK, O'Donnell K. Evaluating mental health difficulties and associated outcomes among HIV-positive adolescents in Tanzania. AIDS Care. 2016 Jul;28(7):825-33. doi: 10.1080/09540121.2016.1139043. Epub 2016 Feb 3.
- Background: PubMed 27851797Ramaiya MK, Sullivan KA, O' Donnell K, Cunningham CK, Shayo AM, Mmbaga BT, Dow DE. A Qualitative Exploration of the Mental Health and Psychosocial Contexts of HIV-Positive Adolescents in Tanzania. PLoS One. 2016 Nov 16;11(11):e0165936. doi: 10.1371/journal.pone.0165936. eCollection 2016.
- Background: PubMed 29058461Gichane MW, Sullivan KA, Shayo AM, Mmbaga BT, O' Donnell K, Cunningham CK, Dow DE. Caregiver role in HIV medication adherence among HIV-infected orphans in Tanzania. AIDS Care. 2018 Jun;30(6):701-705. doi: 10.1080/09540121.2017.1391986. Epub 2017 Oct 23.
- Derived from this study: PubMed 32887558Dow DE, Mmbaga BT, Gallis JA, Turner EL, Gandhi M, Cunningham CK, O'Donnell KE. A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial. BMC Public Health. 2020 Sep 4;20(1):1358. doi: 10.1186/s12889-020-09380-3.
- 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.
Dorothy E Dow, MD, MSc-GH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Intervention in people with Health Behavior and HIV, run by Duke University at 1 site in Tanzania.
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 4 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 7 Oct 2022. 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 Tanzania. 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?
Participant attendance (time frame: weekly for 16 weeks during each intervention wave (over 2 years)). The study lists 5 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 NCT02888288, which also lists 4 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 7 Oct 2022.