HIV PreventionPhase 1/2NCT02179138
Paper Applicator Acceptability Study
A Phase 1/2 study testing TFV 1% gel in people with HIV Prevention, run by CONRAD at 1 site in South Africa.
Trial summary
To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- TFV 1% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- Start not givento Mar 2015
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Women who previously participated in CAPRISA 008
- Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
- Allow access to their CAPRISA 008 data, including study exit data
- Able and willing to provide adequate locator information for study retention purposes
- Sexually active (at least one coital act in the last 3 months prior to screening)
Show all 11Show fewer
- HIV negative
- Negative pregnancy test *
- Agree to use a non-barrier form of contraceptive
- Agree to adhere to study visits and procedures
- breastfeeding is not exclusionary but participants must be informed of the presence of TFV in breast milk in negligible amounts
Who cannot join
- Has creatinine clearance ,<50ml/min, as estimated using the method of Cockcroft and Gault
- Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA Vulindlela Clinical Research Site
Pietermaritzburg, KwaZulu-Natal
About this study
Official title: EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA
To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.
Read the detailed description
CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.
- Conditions
- HIV Prevention
- Being tested
- TFV 1% gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFV 1% gelDrug
| Study group | Role | What they receive |
|---|---|---|
| TFV 1% Gel | Other | TFV 1% gel with the user-filled paper applicator Receives: Drug: TFV 1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall acceptability
Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator
Measured: over 3 months of use
context of use
Description of context of use of user-filled, paper applicator
Measured: over three months
challenges encountered
Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges
Measured: over three months
Applicator Preference
Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator
Measured: Over three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Primary completionMar 2015
Why it stopped: Study no longer relevant based on change in regulatory pathway for TFV 1% gel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Interventional
- Phase
- Phase 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila E Mansoor, Ph.D., Principal investigator, Centre for the AIDS Programme of Research in South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179138
- Sponsor's protocol ID
- CAPRISA 070
- Status last verified
- Apr 2015
- First submitted
- 27 Jun 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA
- ClinicalTrials.gov ID
- NCT02179138
- Acronym / sponsor ID
- CAPRISA 070
- Conditions
- HIV Prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer relevant based on change in regulatory pathway for TFV 1% gel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Primary completion
- Mar 2015 (actual)
- First posted
- 1 Jul 2014 (estimated)
- 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.
To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.
Detailed description
CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TFV 1% Gel | Other | Drug: TFV 1% gelTFV 1% gel with the user-filled paper applicator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years and older
- Women who previously participated in CAPRISA 008
- Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
- Allow access to their CAPRISA 008 data, including study exit data
- Able and willing to provide adequate locator information for study retention purposes
Key exclusion criteria (2 listed)
- Has creatinine clearance ,<50ml/min, as estimated using the method of Cockcroft and Gault
- Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFV 1% gel | Drug | TFV 1% Gel |
Primary outcome
Overall acceptability
Time frame: over 3 months of use
Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator
context of use
Time frame: over three months
Description of context of use of user-filled, paper applicator
challenges encountered
Time frame: over three months
Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges
Applicator Preference
Time frame: Over three months
Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Leila E Mansoor, Ph.D. principal investigator
Centre for the AIDS Programme of Research in South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TFV 1% gel in people with HIV Prevention, run by CONRAD 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 11 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Apr 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall acceptability (time frame: over 3 months of use). The study lists 4 primary outcomes in all. 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 10 Apr 2015.