HivNCT06852508
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use
A study testing TwySHE in people with Hiv and Contraception Behavior, run by University of Colorado, Denver at 1 site in Zambia.
Trial summary
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is: Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Contraception Behavior
- What is being tested?
- TwySHE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteZambia
- Study dates
- 18 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 18 to 24 years
- Current university student
- Not diagnosed with HIV
- Self-report of 3 more HIV risk factors
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is:
- Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia?
Read more
Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention.
Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services.
All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.
Read the detailed description
We are conducting a 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial to determine the effectiveness the TwySHE intervention in Lusaka, Zambia. We will follow all participants for 12 months with regular data collection. All intervention activities will end at 6 months (primary endpoint window), but we will continue to follow and survey participants in both study arms at 12 months to determine long-term post-intervention effectiveness. PrEP and contraception uptake and persistence will be objectively verified using a study medical visit card filled out and signed by health providers. We will also collect and assess behavioral mechanisms hypothesized to be on the casual pathway, including participant knowledge regarding HIV and unintended pregnancy prevention, health beliefs (perceived risk of HIV or unintended pregnancy), perceived social support to access and adhere to HIV/unintended pregnancy prevention methods, stigma, behavioral intention to use PrEP and contraception, and self-efficacy to use PrEP and contraception. Lastly, we will conduct exit interviews with peer-navigators and a sub-sample of participants to explore the implementation outcomes of the trial.
- Conditions
- Hiv, Contraception Behavior
- Being tested
- TwySHE
- Keywords
- HIV prevention, Modern contraception, Pre-exposure prophylaxis, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwySHEBehavioural
Also called mhealth peer navigator intervention
Interpersonal support from trained peers to access and use PrEP and contraception.
| Study group | Role | What they receive |
|---|---|---|
| TwySHE mhealth peer navigator intervention | Experimental | Trained peer navigators will promote PrEP and contraception uptake/persistence among participants by communicating with them in-person or over mobile devices twice per month for 6 months. The first visit (in-person) is focused on building rapport and a trusting relationship with the participant. During the second visit (in-person) and subsequent sessions (in-person or mobile communication), the peer navigators will focus on encouraging, supporting, and helping build the skills of their participants to address their HIV/SRH needs, provide referrals and linkage to available services, and follow up to ensure participants access those services. Subsequent visits will be conducted as needed, depending on the participant. Receives: Behavioral: TwySHE |
| Control | No intervention | Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Self-reported use of PrEP products verified through health clinic documentation
Measured: 6 months
Secondary outcomes (1)
Contraception uptake
Self-reported use of PrEP products verified through health clinic documentation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start18 Feb 2025
- Primary completion28 Feb 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia
- Responsible party
- Sponsor
- Investigators
- Karen M Hampanda, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852508
- Sponsor's protocol ID
- 22-1151
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results after deidentification
Publications
Hampanda K, Amstutz A, Nayame L, Sehrt M, Hamoonga T, Menon JA, Mumbula I, Mulawa M, Nkole E, Matenga FJ, Mugode M, Mweemba O. TwySHE-an mHealth peer-navigator intervention to increase PrEP and contraceptive use among female university students in Zambia: study protocol of a hybrid effectiveness-implementation randomized controlled trial. Trials. 2026 Mar 5;27(1):296. doi: 10.1186/s13063-026-09545-2.
PubMed 41781994
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06852508
- Acronym / sponsor ID
- 22-1151
- Conditions
- Hiv, Contraception Behavior
- Keywords
- HIV prevention, Modern contraception, Pre-exposure prophylaxis, PrEP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Zambia
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is:
- Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia?
Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention.
Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services.
All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.
Detailed description
We are conducting a 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial to determine the effectiveness the TwySHE intervention in Lusaka, Zambia. We will follow all participants for 12 months with regular data collection. All intervention activities will end at 6 months (primary endpoint window), but we will continue to follow and survey participants in both study arms at 12 months to determine long-term post-intervention effectiveness. PrEP and contraception uptake and persistence will be objectively verified using a study medical visit card filled out and signed by health providers. We will also collect and assess behavioral mechanisms hypothesized to be on the casual pathway, including participant knowledge regarding HIV and unintended pregnancy prevention, health beliefs (perceived risk of HIV or unintended pregnancy), perceived social support to access and adhere to HIV/unintended pregnancy prevention methods, stigma, behavioral intention to use PrEP and contraception, and self-efficacy to use PrEP and contraception. Lastly, we will conduct exit interviews with peer-navigators and a sub-sample of participants to explore the implementation outcomes of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| TwySHE mhealth peer navigator intervention | Experimental | Behavioral: TwySHETrained peer navigators will promote PrEP and contraception uptake/persistence among participants by communicating with them in-person or over mobile devices twice per month for 6 months. The first visit (in-person) is focused on building rapport and a trusting relationship with the participant. During the second visit (in-person) and subsequent sessions (in-person or mobile communication), the peer navigators will focus on encouraging, supporting, and helping build the skills of their participants to address their HIV/SRH needs, provide referrals and linkage to available services, and follow up to ensure participants access those services. Subsequent visits will be conducted as needed, depending on the participant. |
| Control | No intervention | –Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Aged 18 to 24 years
- Current university student
- Not diagnosed with HIV
- Self-report of 3 more HIV risk factors
Key exclusion criteria (6 listed)
- Male
- Less than 18 years of age
- Greater than 24 years of age
- Diagnosed with HIV
- Less than 3 self-reported HIV risk behaviors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TwySHEAlso: mhealth peer navigator interventionInterpersonal support from trained peers to access and use PrEP and contraception. | Behavioural | TwySHE mhealth peer navigator intervention |
Primary outcome
PrEP uptake
Time frame: 6 months
Self-reported use of PrEP products verified through health clinic documentation
1 secondary outcome
Contraception uptake
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 41781994Hampanda K, Amstutz A, Nayame L, Sehrt M, Hamoonga T, Menon JA, Mumbula I, Mulawa M, Nkole E, Matenga FJ, Mugode M, Mweemba O. TwySHE-an mHealth peer-navigator intervention to increase PrEP and contraceptive use among female university students in Zambia: study protocol of a hybrid effectiveness-implementation randomized controlled trial. Trials. 2026 Mar 5;27(1):296. doi: 10.1186/s13063-026-09545-2.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Hampanda, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TwySHE in people with Hiv and Contraception Behavior, run by University of Colorado, Denver at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.