Trial · NCT04429061
Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
NCT04429061, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2024-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ. Trials, record NCT04429061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04429061
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
- NCT number
- NCT04429061
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,153 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- HIV Infections, Pregnancy Related, STI, Mental Health Wellness 1
- Interventions
- SKILLZ-Girl curriculum
- First posted
- 2020-06-11
- Last updated
- 2025-11-10
- Results first posted
- 2024-05-08
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Undergoing HIV Testing Within 12 Months | 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. |
| Primary | Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months | 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. |
| Primary | The Percentage of HIV Infected Participants Being Virally Suppressed at 12 Months | 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. |
| Primary | The Percentage of HIV Infected Participants Retained in Care at 3 Months | 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. |
| Primary | The Percentage of HIV Infected Participants Retained in Care at 6 Months | 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. |
| Primary | The Percentage of HIV Infected Participants Retained in Care at 12 Months | 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. |
| Secondary | Number of Participants Who Identified Barriers That Prevent Intervention Participation | Baseline through 12 months | 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. |
| Secondary | 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 | 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. |
| Secondary | Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention. | Baseline through 12 months | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Undergoing HIV Testing Within 12 Months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Percentage of HIV Infected Participants Being Virally Suppressed at 12 Months | 12 months | 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. | ||
| PRIMARY | The Percentage of HIV Infected Participants Retained in Care at 3 Months | 3 months | 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. | ||
| PRIMARY | The Percentage of HIV Infected Participants Retained in Care at 6 Months | 6 months | 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. | ||
| PRIMARY | The Percentage of HIV Infected Participants Retained in Care at 12 Months | 12 months | 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 | ||
| SECONDARY | Number of Participants Who Identified Barriers That Prevent Intervention Participation | Baseline through 12 months | Descriptive statistics and qualitative analysis. Data only collected under enhanced arm. No sessions provided to the SOC arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Data only collected under enhanced arm. No sessions provided to the SOC arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention. | Baseline through 12 months | Data only collected for Enhanced arm. Number represents costs in dollar. No other applicable measure type available. | USD | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Undergoing HIV Testing Within 12 Months | SOC Arm | 361 | Participants | ||
| Number of Participants Undergoing HIV Testing Within 12 Months | Enhanced Arm | 552 | Participants | ||
| Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months | SOC Arm | 214 | Participants | ||
| Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months | Enhanced Arm | 297 | Participants | ||
| Number of Participants Who Identified Barriers That Prevent Intervention Participation | SOC Arm | 0 | Participants | ||
| Number of Participants Who Identified Barriers That Prevent Intervention Participation | Enhanced Arm | 233 | Participants | ||
| Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only. | SOC Arm | 0 | Participants | ||
| Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only. | Enhanced Arm | 276 | Participants | ||
| Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention. | Enhanced Arm | 534255 | USD |
Source ClinicalTrials.gov
Participant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SOC Arm | 1,019 | 23 |
| Overall Study | STARTED | Enhanced Arm | 1,134 | 23 |
| Overall Study | School 1 and 2 | SOC Arm | 38 | 1 |
| Overall Study | School 1 and 2 | Enhanced Arm | 51 | 1 |
| Overall Study | School 3 and 4 | SOC Arm | 37 | 1 |
| Overall Study | School 3 and 4 | Enhanced Arm | 46 | 1 |
| Overall Study | School 5 and 6 | SOC Arm | 44 | 1 |
| Overall Study | School 5 and 6 | Enhanced Arm | 50 | 1 |
| Overall Study | School 7 and 8 | SOC Arm | 31 | 1 |
| Overall Study | School 7 and 8 | Enhanced Arm | 53 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOC Arm | 0 | 1,019 |
| Total, all-cause mortality | Enhanced Arm | 0 | 1,134 |
| Total, other adverse events | SOC Arm | 0 | 1,019 |
| Total, other adverse events | Enhanced Arm | 0 | 1,134 |
| Total, serious adverse events | SOC Arm | 0 | 1,019 |
| Total, serious adverse events | Enhanced Arm | 0 | 1,134 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH116789 | Reaching 90 90 90 in Adolescents in Zambia: Using all our SKILLZ | BOLTON MOORE, CAROLYN; LIU, JENNY XIN | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL INSTITUTE OF MENTAL HEALTH | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SOC Arm vs Enhanced Arm: Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months | Trial comparisons |
| SOC Arm vs Enhanced Arm: Number of Participants Undergoing HIV Testing Within 12 Months | Trial comparisons |
| SOC Arm vs Enhanced Arm: deaths from any cause | Trial comparisons |
| SOC Arm vs Enhanced Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04429061
GET https://conductscience.org/api/trials/v1/NCT04429061/flow?page=2