Trial Outcomes & Findings for SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth (NCT NCT05374109)
NCT ID: NCT05374109
Last Updated: 2026-07-29
Results Overview
HIV RNA measured by blood testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
690 participants
Primary outcome timeframe
6 months post-baseline visit
Results posted on
2026-07-29
Participant Flow
Participant milestones
| Measure |
Ifakara SOC
Ifakara site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Ifakara SYV
Ifakara site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
KCMC/Mawenzi SYV
KCMC/Mawenzi site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
KCMC/Mawenzi SOC
KCMC/Mawenzi site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Mbeya SYV
Mbeya site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
Mbeya SOC
Mbeya site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Mwanza SYV
Mwanza site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
Mwanza SOC
Mwanza site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
|---|---|---|---|---|---|---|---|---|
|
Wave 1
STARTED
|
22
|
22
|
23
|
21
|
22
|
22
|
22
|
22
|
|
Wave 1
COMPLETED
|
15
|
19
|
21
|
12
|
21
|
21
|
19
|
13
|
|
Wave 1
NOT COMPLETED
|
7
|
3
|
2
|
9
|
1
|
1
|
3
|
9
|
|
Wave 2
STARTED
|
22
|
22
|
18
|
20
|
22
|
24
|
22
|
23
|
|
Wave 2
COMPLETED
|
21
|
22
|
17
|
18
|
20
|
22
|
20
|
21
|
|
Wave 2
NOT COMPLETED
|
1
|
0
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Wave 3
STARTED
|
20
|
20
|
21
|
21
|
23
|
21
|
21
|
23
|
|
Wave 3
COMPLETED
|
20
|
20
|
17
|
18
|
0
|
0
|
0
|
0
|
|
Wave 3
NOT COMPLETED
|
0
|
0
|
4
|
3
|
23
|
21
|
21
|
23
|
|
Wave 4
STARTED
|
20
|
20
|
24
|
20
|
23
|
21
|
24
|
19
|
|
Wave 4
COMPLETED
|
16
|
16
|
22
|
19
|
0
|
0
|
0
|
0
|
|
Wave 4
NOT COMPLETED
|
4
|
4
|
2
|
1
|
23
|
21
|
24
|
19
|
Reasons for withdrawal
| Measure |
Ifakara SOC
Ifakara site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Ifakara SYV
Ifakara site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
KCMC/Mawenzi SYV
KCMC/Mawenzi site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
KCMC/Mawenzi SOC
KCMC/Mawenzi site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Mbeya SYV
Mbeya site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
Mbeya SOC
Mbeya site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Mwanza SYV
Mwanza site participants randomized to Sauti ya Vijana (SYV) intervention: Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
Mwanza SOC
Mwanza site participants randomized to Standard of Care (SOC): Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
|---|---|---|---|---|---|---|---|---|
|
Wave 1
Lost to Follow-up
|
7
|
3
|
1
|
9
|
1
|
1
|
3
|
8
|
|
Wave 1
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Wave 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Wave 2
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Wave 2
Lost to Follow-up
|
1
|
0
|
1
|
1
|
1
|
2
|
2
|
1
|
|
Wave 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Wave 2
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Wave 3
Death
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Wave 3
Lost to Follow-up
|
0
|
0
|
4
|
2
|
0
|
0
|
1
|
0
|
|
Wave 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Wave 3
Premature study closure
|
0
|
0
|
0
|
0
|
23
|
19
|
20
|
23
|
|
Wave 4
Death
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Wave 4
Premature study closure
|
0
|
0
|
0
|
0
|
23
|
20
|
24
|
19
|
|
Wave 4
Lost to Follow-up
|
2
|
4
|
2
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Baseline characteristics by cohort
| Measure |
SOC - Standard of Care
n=341 Participants
Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
Total
n=690 Participants
Total of all reporting groups
|
SYV: Sauti ya Vijana (The Voice of Youth Intervention)
n=349 Participants
Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
|---|---|---|---|
|
Age, Continuous
|
17.5 years
STANDARD_DEVIATION 2.5 • n=27 Participants
|
17.5 years
STANDARD_DEVIATION 2.5 • n=267 Participants
|
17.5 years
STANDARD_DEVIATION 2.4 • n=9 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=27 Participants
|
347 Participants
n=267 Participants
|
177 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=27 Participants
|
343 Participants
n=267 Participants
|
172 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
341 Participants
n=27 Participants
|
690 Participants
n=267 Participants
|
349 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
341 Participants
n=27 Participants
|
690 Participants
n=267 Participants
|
349 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Tanzania
|
341 Participants
n=27 Participants
|
690 Participants
n=267 Participants
|
349 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 6 months post-baseline visitPopulation: Includes only participants with HIV RNA measurement at 6-month visit
HIV RNA measured by blood testing
Outcome measures
| Measure |
SYV: Sauti ya Vijana (The Voice of Youth Intervention)
n=307 Participants
Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
SOC - Standard of Care
n=300 Participants
Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
|---|---|---|
|
Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL
|
267 Participants
|
267 Participants
|
SECONDARY outcome
Timeframe: Baseline, months 4 and 12 post-baseline visitHIV RNA measured by blood testing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, months 4, 6 and 12 post-baseline visitHIV RNA measured by blood testing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, months 4, 6 and 12 post-baseline visitHIV RNA measured by blood testing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.HIV RNA measured by blood testing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, months 4, 6, 12 and 18 post-baseline visitSYV Scale - Adherence section (Likert scale - not applicable)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, month 6hair samples sent for analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitPopulation: SDQ was included in the protocol in error. It was not administered as it is more tailored to a younger audience. No SDQ data were collected and no SDQ data will be reported.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Sexual section (Likert scale - N/A)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 6, 12 and 18 months post-baseline visitSYV Scale - Personal section (Likert scale N/A)
Outcome measures
Outcome data not reported
Adverse Events
SYV: Sauti ya Vijana (The Voice of Youth Intervention)
Serious events: 7 serious events
Other events: 53 other events
Deaths: 1 deaths
SOC - Standard of Care
Serious events: 13 serious events
Other events: 74 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
SYV: Sauti ya Vijana (The Voice of Youth Intervention)
n=349 participants at risk
Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
SOC - Standard of Care
n=341 participants at risk
Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
|---|---|---|
|
General disorders
Hospitalization for any reason
|
0.29%
1/349 • Up to 6 months
|
0.00%
0/341 • Up to 6 months
|
|
Psychiatric disorders
Suicide attempt
|
0.29%
1/349 • Up to 6 months
|
0.29%
1/341 • Up to 6 months
|
|
Psychiatric disorders
Self harm - current
|
0.29%
1/349 • Up to 6 months
|
2.3%
8/341 • Up to 6 months
|
|
Social circumstances
Sexual abuse - current
|
1.1%
4/349 • Up to 6 months
|
1.2%
4/341 • Up to 6 months
|
Other adverse events
| Measure |
SYV: Sauti ya Vijana (The Voice of Youth Intervention)
n=349 participants at risk
Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.
|
SOC - Standard of Care
n=341 participants at risk
Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.
|
|---|---|---|
|
Psychiatric Disorders
Depression (PHQ-9 total score ≥ 10)
|
4.6%
16/349 • Up to 6 months
|
5.9%
20/341 • Up to 6 months
|
|
Social Circumstances
Sexual abuse - past
|
4.0%
14/349 • Up to 6 months
|
5.0%
17/341 • Up to 6 months
|
|
Psychiatric Disorders
Anxiety (GAD-7 total score ≥ 10)
|
1.7%
6/349 • Up to 6 months
|
4.1%
14/341 • Up to 6 months
|
|
Psychiatric Disorders
Suicidal Ideation
|
1.7%
6/349 • Up to 6 months
|
2.9%
10/341 • Up to 6 months
|
|
General Disorders
Concerns about mental health or home environment based on staff interaction
|
1.1%
4/349 • Up to 6 months
|
1.2%
4/341 • Up to 6 months
|
|
Social Circumstances
Domestic Disputes
|
0.86%
3/349 • Up to 6 months
|
0.59%
2/341 • Up to 6 months
|
|
Psychiatric Disorders
Self harm - past
|
0.57%
2/349 • Up to 6 months
|
1.2%
4/341 • Up to 6 months
|
|
General Disorders
Poor medication adherence
|
0.57%
2/349 • Up to 6 months
|
0.88%
3/341 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place