Trial Outcomes & Findings for Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ (NCT NCT04429061)

NCT ID: NCT04429061

Last Updated: 2025-11-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2153 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-11-10

Participant Flow

Unit of analysis: Schools

Participant milestones

Measure	SOC Arm Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Overall Study STARTED	1019 23	1134 23
Overall Study School 1 and 2	38 1	51 1
Overall Study School 3 and 4	37 1	46 1
Overall Study School 5 and 6	44 1	50 1
Overall Study School 7 and 8	31 1	53 1
Overall Study School 9 and 10	50 1	50 1
Overall Study School 11 and 12	50 1	50 1
Overall Study School 13 and 14	50 1	50 1
Overall Study School 15 and 16	29 1	50 1
Overall Study School 17 and 18	52 1	48 1
Overall Study School 19 and 20	50 1	47 1
Overall Study School 21 and 22	35 1	51 1
Overall Study School 23 and 24	50 1	51 1
Overall Study School 25 and 26	36 1	48 1
Overall Study School 27 and 28	50 1	40 1
Overall Study School 29 and 30	35 1	51 1
Overall Study School 31 and 32	51 1	54 1
Overall Study School 33 and 34	52 1	52 1
Overall Study School 35 and 36	43 1	42 1
Overall Study School 37 and 38	51 1	45 1
Overall Study School 39 and 40	31 1	52 1
Overall Study School 41 and 42	49 1	50 1
Overall Study School 43 and 44	52 1	50 1
Overall Study School 45 and 46	53 1	53 1
Overall Study COMPLETED	954 23	1043 23
Overall Study NOT COMPLETED	65 0	91 0

Reasons for withdrawal

Measure	SOC Arm Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Overall Study Lost to Follow-up	62	87
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SOC Arm n=1019 Participants Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=1134 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club	Total n=2153 Participants Total of all reporting groups
Age, Categorical <=18 years	857 Participants n=5 Participants	996 Participants n=20 Participants	1853 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=5 Participants	138 Participants n=20 Participants	300 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	1019 Participants n=5 Participants	1134 Participants n=20 Participants	2153 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1019 Participants n=5 Participants	1134 Participants n=20 Participants	2153 Participants n=40 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment Zambia	1019 participants n=5 Participants	1134 participants n=20 Participants	2153 participants n=40 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Measure	SOC Arm n=918 Participants Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=1021 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Number of Participants Undergoing HIV Testing Within 12 Months	361 Participants	552 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	SOC Arm n=816 Participants Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=859 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months	214 Participants	297 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Data was not collected due to the low proportion of participants who were positive. In addition, there was no way to link the partcipants to the clinical record to access viremia.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Data was not collected due to the low proportion of participants who were positive. In addition, there was no way to link the partcipants to the clinical record to access viremia.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Data was not collected due to the low proportion of participants who were positive. In addition, there was no way to link the partcipants to the clinical record to access viremia.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Data was not collected due to the low proportion of participants who were positive. In addition, there was no way to link the partcipants to the clinical record to access viremia

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Descriptive statistics and qualitative analysis. Data only collected under enhanced arm. No sessions provided to the SOC arm.

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.

Outcome measures

Measure	SOC Arm Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=1134 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Number of Participants Who Identified Barriers That Prevent Intervention Participation	0 Participants	233 Participants

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Data only collected under enhanced arm. No sessions provided to the SOC arm.

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.

Outcome measures

Measure	SOC Arm Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=1134 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only.	0 Participants	276 Participants

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Data only collected for Enhanced arm. Number represents costs in dollar. No other applicable measure type available.

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.

Outcome measures

Measure	SOC Arm Standard of care (SOC): the sexual reproductive curriculum which is implemented by the schools as part of mandatory SRH education.	Enhanced Arm n=1134 Participants 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 SKILLZ-Girl curriculum: Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention.	—	534255 USD

Adverse Events

SOC Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Carolyn Bolton

University of Alabama at Birmingham

Phone: 966841034

Email: Carolyn.Bolton@cidrz.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place