N/A
Completed N=2,153
Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
HIV · Pregnancy Related · STI · Mental Health Wellness 1
Source: ClinicalTrials.gov NCT04429061 ↗
Enrolled (actual)
2,153
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Number of Participants Undergoing HIV Testing Within 12 Months — 361; 552 Participants
Summary
"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl - implemented in schools as part of a 10-week program culminating in a tournament event; (2) SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are HIV-positive.
The programs work together to build a continued support system which encourages uptake of Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for HV-positive participants) and continued engagement with health services over the long-term (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV treatment and care).
The study team has developed an enhanced SKILLZ-Girl offering, which will include a comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the implementation of sessions and the additional offering of HIVST and contraceptive services at the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The central hypothesis is that this enhanced curriculum will increase HIV testing and contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm). The investigators further hypothesize that the intervention in the enhanced arm will positively and directly affect a number of mediating factors including attendance at soccer events where community-based SRH services are offered, SRH knowledge, empowerment, self-confidence, and perceptions of gender balance, and (reduced) stigma.
For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase disclosure to family and partners, increase feelings of social support, empowerment, self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention in HIV care and treatment.
This study will be conducted in up to 32 secondary schools that GRS currently serves in the Lusaka Urban District.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Undergoing HIV Testing Within 12 Months |
361; 552 | — |
| PRIMARY Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months |
214; 297 | — |
| PRIMARY The Percentage of HIV Infected Participants Being Virally Suppressed at 12 Months |
— | — |
| PRIMARY The Percentage of HIV Infected Participants Retained in Care at 3 Months |
— | — |
| PRIMARY The Percentage of HIV Infected Participants Retained in Care at 6 Months |
— | — |
| PRIMARY The Percentage of HIV Infected Participants Retained in Care at 12 Months |
— | — |
| SECONDARY Number of Participants Who Identified Barriers That Prevent Intervention Participation |
0; 233 | — |
| SECONDARY Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only. |
0; 276 | — |
| SECONDARY Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention. |
534255 | — |
Eligibility Criteria
Inclusion Criteria
- The student is >16 years of age prior to the first session of SKILLZ-Girl or the student will turn 16 years of age before the last session of SKILLZ-Girl (ie prior to the event)
- Is enrolled in one of the SKILLZ STUDY schools
- Is able to converse in and comprehend either Nyanja, English and/or Bemba
- The Parent/Guardian of the participant has consented for the participant to take part in the study
Exclusion Criteria
- The student has a mental disability that would interfere with their ability to give informed consent
Data sourced from ClinicalTrials.gov (NCT04429061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.