Mobile health intervention to boost HIV prevention and contraception use among female students
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use Among Sexually Active Female University Students in Zambia: Study Protocol of a Hybrid Effectiveness-implementation Randomized Controlled Trial
This study is testing a mobile health program to see if it can help young women in university use HIV prevention and contraception more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years to 24 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT06852508 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the TwySHE intervention, a mobile health peer navigator program, in increasing the use of HIV pre-exposure prophylaxis (PrEP) and contraception among at-risk female university students aged 18-24 in Lusaka, Zambia. Participants will be randomly assigned to receive either the TwySHE intervention or standard treatment, with peer navigators providing education and support to help them access these health services. The study will track participants over 12 months, assessing their health behaviors and the impact of the intervention through surveys and medical verification of PrEP and contraception use.
Who should consider this trial
Good fit: Ideal candidates for this study are female university students aged 18-24 who are at risk for HIV and have not been diagnosed with the virus.
Not a fit: Patients who are male, outside the age range of 18-24, or who do not meet the criteria for HIV risk factors will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly increase the uptake and continuation of HIV prevention methods among young women, reducing their risk of HIV and unintended pregnancies.
How similar studies have performed: Other studies have shown success with mobile health interventions in promoting health behaviors, suggesting that this approach may be effective, although the specific context of this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Aged 18 to 24 years * Current university student * Not diagnosed with HIV * Self-report of 3 more HIV risk factors Exclusion Criteria: * Male * Less than 18 years of age * Greater than 24 years of age * Diagnosed with HIV * Less than 3 self-reported HIV risk behaviors * Not a university student
Where this trial is running
Lusaka
- University of Zambia — Lusaka, Zambia (Recruiting)
Study contacts
- Principal investigator: Karen M Hampanda, PhD — University of Colorado, Denver
- Study coordinator: Karen M Hampanda, PhD
- Email: KAREN.HAMPANDA@CUANSCHUTZ.EDU
- Phone: 3037487805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.