Neisseria GonorrheaARISENCT06570733
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
An observational study of Neisseria Gonorrhea and Trichomoniasis Vaginalis, run by Wits RHI Research Centre Clinical Research Site at 1 site in South Africa.
Trial summary
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the acceptability of point-of-care STI testing plus Expedited Partner Therapy (EPT) and its… Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Neisseria Gonorrhea, Trichomoniasis Vaginalis, Chlamydia Trachomatis Infection
- How many people
- 305 participants
- Where
- 1 siteSouth Africa
- Study dates
- 11 Feb 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Approximately 400 non-pregnant, HIV-negative, cis-gender AGYW aged 16-25, who have recently initiated oral PrEP or who are interested in initiating oral PrEP and are diagnosed with an STI at screening (C. trachomatis, N. gonorrhoeae, or T. vaginalis).
Who may be able to join
- Cisgender girls and women (16-25 years of age, inclusive)
- Vaginal sex with a cisgender male partner in the last three months
- CT, GC, or TV detected at screening
- Willing to return for quarterly study visits
- Not currently pregnant and not planning to become pregnant in the next 12 months
- Using or willing to initiate a highly effective method of contraception*
Show all 9Show fewer
- HIV-uninfected
- Interested in initiating oral PrEP
- No known contraindications to FTC or TDF
Who cannot join
- At Screening or Enrollment, participant reports known adverse reaction to FTC or TDF.
- At Screening or Enrollment, has single or dual rapid Antibody positive reactive HIV-1 test.
- At Screening or Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
- As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
- Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the acceptability of point-of-care STI testing plus Expedited Partner Therapy (EPT) and its impact on the incidence of common curable STIs over 12 months of follow-up. The social-behavioral scientist will undertake qualitative interviews with participants and their male partners to identify facilitators and barriers to EPT uptake and conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the cost of standard of care. Findings from the proposed research will provide essential knowledge for national policymakers to advance approaches to STI screening and treatment that will lead to improvements in AGYW sexual reproductive health and reductions in STIs. The data generated from this project are essential to inform efforts to reduce the burden of STIs and HIV-1 in women and achieve the 2030 Sustainable Development Goals, which includes substantial reductions in HIIV and STIs in key at-risk populations. This project will support global efforts to substantially reduce STIs in key populations.
Read the detailed description
The study aims to estimate the incidence of STIs (Chlamydia trachomatis, Neisseria gonorrhea, and Trichomoniasis vaginalis) among Adolescent Girls and Young Women (AGYW) initiating PrEP who received point-of-care STI testing plus Expedited Partner Therapy (EPT) and those who received point-of-care STI testing but declined EPT. To assess the acceptability of point-to-care STI testing plus EPT for AGYW initiating oral PrEP and its impact on exposure to social harms. To assess the male partner's response and acceptability among those who received EPT. Estimate the cost of implementing rapid point-of-care diagnostic STI testing and EPT for AGYW in South Africa using PrEP compared to standard syndromic management. The study design aims to conduct a prospective cohort study among adolescent girls and young women (AGYW) and assess the incidence of select STIs detected by point-of-care testing, including C.trachomatis, N. gonorrhea, or T. vaginalis, over 12 months of follow-up. Moreover, to assess the acceptability of expedited partner treatment offered to AGYW with an STI and their partners who received EPT. To conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the standard cost.
What is being measured
The primary outcome is the main question the study is designed to answer.
GeneXpert
A PCR instrument used to diagnose chlamydia trachomatis and gonorrhea.
Measured: 2 years
Secondary outcomes (1)
Osom rapid testing kit
A rapid testing kit to diagnose trichomoniasis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start11 Feb 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria GonorrheaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wits RHI Research Centre Clinical Research Site
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Thesla Palanee-Phillips, Wits RHI Research Centre Clinical Research Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570733
- Sponsor's protocol ID
- ARISE
- Acronym
- ARISE
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' study information will not be released without their written permission, except as necessary for review, monitoring, and/or auditing by the following: * Representatives of the US Federal Government, the US Office for Human Research Protections, National Institutes of Health (NIH) and/or contractors of the NIH, and other local, US, and international regulatory entities * Study staff * IRBs/ECs Overall study results will be disseminated and published by the University of Washington.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
- ClinicalTrials.gov ID
- NCT06570733
- Acronym / sponsor ID
- ARISE / ARISE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Wits RHI Research Centre Clinical Research SiteUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Aug 2024 (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.
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the acceptability of point-of-care STI testing plus Expedited Partner Therapy (EPT) and its impact on the incidence of common curable STIs over 12 months of follow-up. The social-behavioral scientist will undertake qualitative interviews with participants and their male partners to identify facilitators and barriers to EPT uptake and conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the cost of standard of care. Findings from the proposed research will provide essential knowledge for national policymakers to advance approaches to STI screening and treatment that will lead to improvements in AGYW sexual reproductive health and reductions in STIs. The data generated from this project are essential to inform efforts to reduce the burden of STIs and HIV-1 in women and achieve the 2030 Sustainable Development Goals, which includes substantial reductions in HIIV and STIs in key at-risk populations. This project will support global efforts to substantially reduce STIs in key populations.
Detailed description
The study aims to estimate the incidence of STIs (Chlamydia trachomatis, Neisseria gonorrhea, and Trichomoniasis vaginalis) among Adolescent Girls and Young Women (AGYW) initiating PrEP who received point-of-care STI testing plus Expedited Partner Therapy (EPT) and those who received point-of-care STI testing but declined EPT. To assess the acceptability of point-to-care STI testing plus EPT for AGYW initiating oral PrEP and its impact on exposure to social harms. To assess the male partner's response and acceptability among those who received EPT. Estimate the cost of implementing rapid point-of-care diagnostic STI testing and EPT for AGYW in South Africa using PrEP compared to standard syndromic management. The study design aims to conduct a prospective cohort study among adolescent girls and young women (AGYW) and assess the incidence of select STIs detected by point-of-care testing, including C.trachomatis, N. gonorrhea, or T. vaginalis, over 12 months of follow-up. Moreover, to assess the acceptability of expedited partner treatment offered to AGYW with an STI and their partners who received EPT. To conduct a comparative cost analysis to estimate the cost per person tested using point-of-care STI testing with and without EPT incremental to the standard cost.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Approximately 400 non-pregnant, HIV-negative, cis-gender AGYW aged 16-25, who have recently initiated oral PrEP or who are interested in initiating oral PrEP and are diagnosed with an STI at screening (C. trachomatis, N. gonorrhoeae, or T. vaginalis).
Key inclusion criteria (9 listed)
- Cisgender girls and women (16-25 years of age, inclusive)
- Vaginal sex with a cisgender male partner in the last three months
- CT, GC, or TV detected at screening
- Willing to return for quarterly study visits
- Not currently pregnant and not planning to become pregnant in the next 12 months
Key exclusion criteria (5 listed)
- At Screening or Enrollment, participant reports known adverse reaction to FTC or TDF.
- At Screening or Enrollment, has single or dual rapid Antibody positive reactive HIV-1 test.
- At Screening or Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
- As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
- Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GeneXpert
Time frame: 2 years
A PCR instrument used to diagnose chlamydia trachomatis and gonorrhea.
1 secondary outcome
Osom rapid testing kit
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No. Participants' study information will not be released without their written permission, except as necessary for review, monitoring, and/or auditing by the following: * Representatives of the US Federal Government, the US Office for Human Research Protections, National Institutes of Health (NIH) and/or contractors of the NIH, and other local, US, and international regulatory entities * Study staff * IRBs/ECs Overall study results will be disseminated and published by the University of Washington.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neisseria Gonorrhea and Trichomoniasis Vaginalis, run by Wits RHI Research Centre Clinical Research Site at 1 site in South Africa.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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 South Africa. 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?
Results are not available in the source record.
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?
GeneXpert (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.