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HIVPhase 2/3NCT01691768

Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services

A Phase 2/3 study testing 1% tenofovir gel in people with HIV, run by Centre for the AIDS Programme of Research in South Africa at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services. 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
What is being tested?
1% tenofovir gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
2 sitesSouth Africa
Study dates
Oct 2012to Dec 2015
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 an ARV prevention study
  • Currently utilizing or agreeing to attend designated public sector family planning services
  • Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
  • 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 10Show fewer
  • HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
  • Negative pregnancy test performed by study staff within 21 days of enrollment
  • Agree to use a non-barrier form of contraceptive
  • Agree to adhere to study visits and procedures

Who cannot join

  • Has a creatinine clearance < 50ml/min
  • 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 study outcome data, or otherwise interfere with achieving the study objectives

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • CAPRISA eThekwini Clinical Research Site

    Durban, KwaZulu-Natal, 4001

  • CAPRISA Vulindlela Clinical Research Site

    Pietermaritzburg, KwaZulu-Natal

Other trials in South Africa

About this study

Official title: Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa

The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.

Read the detailed description

The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).

All women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.

The primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.

Conditions
HIV
Being tested
1% tenofovir gel
Keywords
microbicides, women, HIV prevention, PrEP, Tenofovir gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1% tenofovir gelDrug

    Participants will be randomized to receive 1% tenofovir gel through either:

    • Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or
    • The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).
Study groups in NCT01691768
Study groupRoleWhat they receive
InterventionExperimental1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery
Receives: Drug: 1% tenofovir gel
ControlActive comparatormonthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics
Receives: Drug: 1% tenofovir gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)

    The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days.

    Measured: Between 2012 to 2015, up to 28 months

Secondary outcomes (8)

  1. HIV Incidence Rates

    Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one.

    Measured: Between 2012 and 2015, up to 28 months

  2. Pregnancy Incidence Rates

    Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one.

    Measured: Between 2012 and 2015, up to 28 months

  3. Percentage of Participants Achieving Adherence >80%.

    Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30.

    Measured: Between 2012 and 2015, up to 28 months

  4. HIV Viral Load Among HIV Seroconverters

    This is mean log transformed HIV viral load measured at the first visit post HIV infection.

    Measured: Between 2012 and 2015, up to 28 months

  5. Tenofovir Resistance Among HIV Seroconverters

    Measured: Between 2012 and 2015, up to 28 months

  6. Human Papillomavirus Incidence Rates

    For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test.

    Measured: Between 2012 and 2015, up to 28 months

  7. Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up

    Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable.

    Measured: All participants with drug levels at 12 months of follow-up

  8. Product Acceptability

    This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire.

    Measured: At study completion, up to 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2015
  4. Study completionDec 2015

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691768
Sponsor's protocol ID
CAPRISA008
Status last verified
Nov 2019
First submitted
5 Jul 2012
Last updated
26 Nov 2019
Data monitoring committee
Yes

Publications

  • Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.

    PubMed 20643915

  • Mngadi KT, Singh JA, Mansoor LE, Wassenaar DR. Undue inducement: a case study in CAPRISA 008. J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27.

    PubMed 28348164

  • Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.

    PubMed 25527071

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 1% tenofovir gel in people with HIV, run by Centre for the AIDS Programme of Research in South Africa at 2 sites 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 10 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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) (time frame: Between 2012 to 2015, up to 28 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 NCT01691768, which also lists 3 linked publications.

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 Nov 2019.

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