Adherence, Medication, HIV-1-infection, Mental Health Issue
Conditions
Keywords
HIV-1, Adolescent, Youth, Mental Health, Africa, Tanzania, Medication Adherence
Brief summary
The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.
Detailed description
The rigorous experimental design includes a pilot study followed by a parallel-arm randomized control trial (RCT). The pilot will include approximately eight consenting members of the youth community advisory board (CAB) at each site location prior to the RCT. If a youth CAB does not currently exist at each site, one will be formed. Although the investigators have strong pilot data for the SYV intervention from Moshi, the pilot test proposed herein will help ensure recruitment, enrollment, intervention delivery, supervision, measurement technology and logistics run as expected at each site (Moshi, Mbeya, Mwanza, Ifakara). The pilot study will be comprised of 8 participants recruited at each site. Subsequently, for the RCT, we will individually randomize up to 750 participants to receive the SYV intervention or SOC (standard of care) to achieve 90% power to detect a 10 percentage point difference between arms in the primary outcome of virologic suppression at the two-tailed 5% significance level, accounting for clustering by SYV group in the intervention arm. The intervention will be rolled out across four main sites, in four different Tanzanian regions, and in four waves separated in time by 6 months. There will be two SYV groups per wave at each site (\ 8 groups per site) A study visit for all participants will be conducted baseline and approximately 4 months (T1), 6-, 12-, and 18-months post-baseline (T2, T3, T4) with 6-months post baseline being the primary endpoint. At 12 months post-baseline (T3), those randomized to the SYV intervention will receive a one-session SYV booster to improve content retention and study engagement as has been shown in prior studies.
Interventions
BEHAVIORALSYV: Sauti ya Vijana (The Voice of Youth intervention)
Mental health is associated with ART adherence and HIV outcomes. SYV was designed to address the specific challenges of young people living (YPLWH) with HIV in Tanzania. SYV includes 10 group sessions (two sessions held jointly with caregivers) lasting approximately 90 minutes and two individual sessions delivered by trained young adult group leaders who use a manualized protocol that is designed to scale in low resource settings. The intervention is applied to the Social Action Theory (SAT), a theoretical framework used to determine factors that influence health behavior. Building off a SAT resilience framework for YPLWH, components of evidence-based treatment models to influence cognitive, self, and social regulation to improve behavioral health outcomes will be strategically used.
Sponsors
Duke University
National Institute of Mental Health (NIMH)
Kilimanjaro Christian Medical Centre, Tanzania
National Institute for Medical Research, Tanzania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The research assistant asking participants questions and the statistician are masked (not aware to which group participants were randomized).
Intervention model description
Restricted randomization will be used to balance the randomization across both study arms by site, sex, and enrollment HIV RNA (\<400 copies/mL or ≥400 copies/mL). Those randomized to receive the SYV intervention will be assembled into 33 groups of 10-11 participants per group. Those randomized to SOC will continue to receive routine care, which will be clearly defined by each site. The outcomes assessor and statisticians will be masked to participant study arm through the 6-month study visit (primary aim).
Eligibility
Sex/Gender
ALL
Age
10 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Youth between the ages of 10 and 24 years of age * Attending the enrolling adolescent HIV clinic * Are fully disclosed and aware of their HIV status * Receiving ART for a minimum of 6 months * If ≥ 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 the 10 weekly SYV sessions and 2 individual sessions
Exclusion criteria
* Active psychosis * Developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL | 6 months post-baseline visit | HIV RNA measured by blood testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL | Baseline, months 4 and 12 post-baseline visit | HIV RNA measured by blood testing |
| Change in Virologic Suppression as Measured by Number of Participants With a HIV RNA <200 Copies/mL | Baseline, months 4, 6 and 12 post-baseline visit | HIV RNA measured by blood testing |
| Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <50 Copies/mL | Baseline, months 4, 6 and 12 post-baseline visit | HIV RNA measured by blood testing |
| Change in HIV RNA Log Scale | Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care. | HIV RNA measured by blood testing |
| Change in Anti-retroviral Therapy (ART) Adherence as Measured by SYV (Sauti ya Vijana) Scale - Adherence Section | Baseline, months 4, 6, 12 and 18 post-baseline visit | SYV Scale - Adherence section (Likert scale - not applicable) |
| Change in Anti-retroviral Therapy (ART) Adherence as Measured by Concentration of ART Medication(s) in Hair Sample | Baseline, month 6 | hair samples sent for analysis |
| Change in Mental Health Status as Measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - General Anxiety Disorder-7 (GAD-7) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice |
| Change in Mental Health Status as Measured by SYV Scale - Patient Health Questionnaire-9 (PHQ-9) Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Patient Health Questionnaire-9 (PHQ-9) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice |
| Change in Mental Health Status as Measured by SYV Scale - Strengths and Difficulties Questionnaire (SDQ) Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Strengths and Difficulties Questionnaire (SDQ) section (Likert scale 0 never true of me to 2 usually true of me) 0 or 2 can be most positive or most negative choices depending on the question |
| Change in Mental Health Status as Measured by SYV Scale - Self-Esteem Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive) |
| Change in Coping Habits as Measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section (Likert scale - 5 options from Always to Never - Never is the most positive choice, 5 options Many Times, A few times, Once, Never or Refused - Never is the most positive choice, 4 options None, Little, Much and Most - no choice is most positive and 3 options are Yes, No or Not Sure - No is the most positive choice) |
| Change in Resilience as Measured by SYV Scale - Adapted People Living With HIV Resilience Scale | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Adapted People Living with HIV Resilience Scale (Likert scale 5 options from strongly disagree to strongly agree - strongly agree is the most positive choice) |
| Change in Stigma as Measured by SYV Scale - Stigma Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice) |
| Change in Overall Quality of Life Measured by SYV Scale - Quality of Life (QOL) | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Quality of Life (QOL) (Likert scale 5 options from very poor/very dissatisfied to very good/very satisfied - very good/very satisfied is the most positive choice) |
| Change in Gender Based Violence as Measured by SYV Scale - Violence Against Partner Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice) |
| Change in Gender Based Violence as Measured by SYV Scale - Violence Perpetration Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice) |
| Change in Disclosure as Measured by SYV Scale - Stigma Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - strongly disagree is the most positive choice) and Sexual section (Likert scale - N/A) |
| Change in HIV Knowledge as Measured by SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice) |
| Change in Sexual High-risk Behaviors as Measured by SYV Scale - Sexual Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Sexual section (Likert scale - N/A) |
| Change in Substance Abuse High-risk Behaviors as Measured by SYV Scale - Personal Section | Baseline, 4, 6, 12 and 18 months post-baseline visit | SYV Scale - Personal section (Likert scale N/A) |
Countries
Tanzania
Contacts
PRINCIPAL_INVESTIGATORDorothy E Dow, MD
Duke University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 17.5 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 690 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 341 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Tanzania | 690 Participants |
| Sex: Female, Male Female | 347 Participants |
| Sex: Female, Male Male | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 349 | 6 / 341 |
| other Total, other adverse events | 53 / 349 | 74 / 341 |
| serious Total, serious adverse events | 7 / 349 | 13 / 341 |
Outcome results
None listed