Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ

NCT04429061 | Completed Results

• 2 other identifiers: IRB-300002251R01MH116789
• Study Type: interventional
• Target: 2,153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Pregnancy Related; STI; Mental Health Wellness 1

Keywords

Adolescents; Zambia; Football

Outcome Measures

Primary Outcomes (6)

• Number of Participants Undergoing HIV Testing Within 12 Months

  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.

  12 months

• Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months

  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.

  12 months

• The Percentage of HIV Infected Participants Being Virally Suppressed at 12 Months

  The percentage of participants, testing HIV positive, who have an undetectable viral load (as defined by the laboratory doing the test) after one year on treatment. Collected from routine laboratory data.

  12 months

• The Percentage of HIV Infected Participants Retained in Care at 3 Months

  The percentage of participants, testing HIV positive, who are actively retained in care at 3 months ie are not more than 7 days late for a scheduled appointment. Determined using the electronic medical record.

  3 months

• The Percentage of HIV Infected Participants Retained in Care at 6 Months

  The percentage of participants, testing HIV positive, that have made their scheduled visit to the clinic within the first at 6 months of enrolment. (less than 7 days late), using the electronic medical record.

  6 months

• The Percentage of HIV Infected Participants Retained in Care at 12 Months

  The percentage of participants, testing HIV positive, who attend their scheduled visits within the first 12 months of enrolment (less than seven days late). determined through the electronic medical record.

  12 months

Secondary Outcomes (3)

• Number of Participants Who Identified Barriers That Prevent Intervention Participation

  Baseline through 12 months

• Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only.

  Baseline through 12 months

• Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention.

  Baseline through 12 months

Study Arms (2)

SOC Arm

NO INTERVENTION

Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.

Enhanced Arm

ACTIVE COMPARATOR

The SKILLZ-Girl Curriculum, plus the graduation event (including HIVST + access to family planning) and home based delivery of commodities with subsequent encouragement to be involved with SKILLZ-Clubs at their school

Behavioral: SKILLZ-Girl curriculum

Interventions

SKILLZ-Girl curriculum BEHAVIORAL

Participation in the SKILLZ-Girl curriculum and SKILLZ-Club

Enhanced Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The student has a mental disability that would interfere with their ability to give informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of California, San Francisco: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator
• Grassroot Soccer: collaborator
• Washington University School of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Centre of Infectious Disease Research Zambia

Lusaka, 10101, Zambia

Location

Related Publications (1)

• Chiu C, Mulubwa C, Mkandawire B, Musonda M, Katota N, Chipungu J, Boettiger D, Padian N, Moore CB, Liu JX. Evaluation of the SKILLZ intervention to promote HIV testing and contraception uptake in adolescent girls in Lusaka, Zambia: A cluster-randomized trial. PLOS Glob Public Health. 2025 Oct 29;5(10):e0005375. doi: 10.1371/journal.pgph.0005375. eCollection 2025.

  PMID: 41160627 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a school study that was conducted during the COVID-19 period and schools were closed for protracted periods of time. In addition, community mistrust around COVID-19 and COVID vaccinations led to large numbers of pupils not returning to school once schools were re-opened. This limited our ability to follow participants longitudinally. General distrust of the medical system made girls resistant to sharing clinical data around HIV.

Results Point of Contact

• Title: Dr Carolyn Bolton
• Organization: University of Alabama at Birmingham

Carolyn.Bolton@cidrz.org

966841034

Study Officials

• Carolyn Bolton, MPH, MD

  UAB/ CIDRZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomised. Randomization at the school level defines a school as receiving arm one or arm two.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: June 11, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 10, 2025
• Results First Posted: May 8, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared with requisite co-investigators on a rolling basis in order to conduct interim analysis
• Access Criteria: Must be a co-investigator

Locations

ZA (1)