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Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
NA trial testing SKILLZ-Girl curriculum in HIV Infections in 2,153 participants. Completed in 31 December 2023.
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 2,153 |
| Start date | 1 February 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Zambia |
University of Alabama at Birmingham
16 and older, female only, with HIV Infections or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants, enrolled in the study, undergoing HIV testing (HIVST our Determine tests) over 1 year. Collected from facility testing registers and community testing registers.
| Group | Value | 95% CI |
|---|---|---|
| SOC Arm | 361 | |
| Enhanced Arm | 552 |
Number of participants, enrolled in the study, accessing contraception, pre-exposure prophylaxis or post exposure prophylaxis over 1 year. Determined through the electronic medical record and clinic registers.
| Group | Value | 95% CI |
|---|---|---|
| SOC Arm | 214 | |
| Enhanced Arm | 297 |
Record and track key barriers through review of routine program data that prevent participants from engaging with the intervention. ie through review of the data collected by coaches from feedback from participants, FGD's and IDI's. During this COVID-19 period, we may be limited or may need to revise our anticipated collection of study results. The study record will reflect these changes as we navigate through the course of the study.
| Group | Value | 95% CI |
|---|---|---|
| SOC Arm | 0 | |
| Enhanced Arm | 233 |
Each session that is conducted will be documented including number of participants in attendance (assessed via attendance registers and routine program data). Data only collected under enhanced arm. No sessions provided to the SOC arm.
| Group | Value | 95% CI |
|---|---|---|
| SOC Arm | 0 | |
| Enhanced Arm | 276 |
Costs will include the personnel to manage the intervention, financial incentives, and other related miscellaneous costs. These will be collected by the program manager and study team, based on actual costs. Costs were mainly collated from the intervention implementers' financial and utilisation data 230 documents and invoices were provided to the trial administration. Data was only collected under the enhanced arm. No costs collected for the SOC arm.
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Arm | 534255 |
"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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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