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HIVNCT03988387

IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

A study testing Peer Support (PS), Reminder and Resource Transfer (RRT) and daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] in people with HIV, run by Columbia University at 1 site in Kenya.

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

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer… 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
What is being tested?
Peer Support (PS), Reminder and Resource Transfer (RRT) and daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteKenya
Study dates
31 Oct 2019to 10 Mar 2022
Phase
Interventional
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 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Report no previous diagnosis of HIV infection
  • Report being a cisgender female or transgender female
  • Report being between 18-24 years of age
  • Report living or working in study area
  • Report intention to stay in study area for 24 months
  • Report exchange sex with men for goods, money, favors or other services in past 3 months
Show all 9Show fewer
  • Report no previous or recent (within the last 3 months) PrEP use
  • Able to complete study procedures in English, Kiswahili or Dholuo
  • Willingness to be randomized and adhere to study interventions according to eligibility, including PrEP

Who cannot join

  • Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
  • Unable to provide informed consent for study procedures
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the principle investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  • Reports plan to leave area in the next 24 months

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Tuungane Centre

    Kisumu

Other trials in Kenya

About this study

Official title: IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

Read the detailed description

The overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (PS) and reminders plus resource transfer (RRT), in combination with daily oral pre-exposure prophylaxis (PrEP) to optimize PrEP adherence among young in Kisumu, Kenya. Pre-exposure prophylaxis (PrEP) is a promising biomedical HIV prevention intervention. Findings from placebo-controlled efficacy trials highlight the need for adherence support to achieve PrEP efficacy and public health impact.

Conditions
HIV
Being tested
Peer Support (PS), Reminder and Resource Transfer (RRT), daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
Keywords
Pre-exposure prophylaxis (PrEP), HIV prevention, Adherence

What participants receive

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

  • Peer Support (PS)Behavioural

    Participants randomized to the PS arm will be assigned a trained peer supporter. The peer supporters (PSr) will establish rapport and build trusting relationships with participants in order to increase self-efficacy and motivation to adhere to the daily PrEP regimen and to engage in HIV prevention behaviors, in general. The PSrs will assess for facilitators and barriers to PrEP adherence, conduct adherence counseling, and provide ongoing social and practical support (e.g. tailored appointment reminders, accompanying participants to medical appointments, and providing skills building for effective relationships with study site providers). PSrs will communicate with the participant on at least a weekly basis either in person or by phone and will track those who miss scheduled study visits. Participants will be encouraged to contact their PSrs in case of questions or concerns. For any clinical question, the peer supporter will direct the participant to the study nurse.

  • Reminder and Resource Transfer (RRT)Behavioural

    Participants who are randomized to the RRT arm will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is "Remember to look after yourself today, See you tomorrow." Participants will be requested to respond to the message with a brief answer. Participants will be advised that each answered text counts as a point toward resource transfer that can be redeemed at scheduled study visits in the form of a small gift, such as cosmetics, personal care items, accessories, or airtime.The value of the reward increases with points.

  • daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]Drug

    All participants will receive a one-month supply of daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] for the first month of enrollment.

Study groups in NCT03988387
Study groupRoleWhat they receive
Peer Support PS)ExperimentalParticipants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.
Receives: Behavioral: Peer Support (PS); Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
Reminders and Resource Transfer (RRT)ExperimentalParticipants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.
Receives: Behavioral: Reminder and Resource Transfer (RRT); Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]

What is being measured

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

  1. PrEP Adherence between PS and RRT arms

    Proportion of participants with ARV in plasma at 12-month visit

    Measured: 12 months

Secondary outcomes (11)

  1. PrEP Adherence between PS and RRT arms, any visit

    Proportion of participants with detectable ARV in plasma at any visit

    Measured: At all visits

  2. PrEP Adherence between PS and RRT arms, self-report

    Proportion who report > 90% adherence by self-report

    Measured: At all visits

  3. PrEP adherence across PS and RRT arms

    Proportion of participants with ARV in plasma at 18- and 24- month visits

    Measured: 18 and 24 months

  4. HIV risk behavior during PrEP use, propensity score

    Comparison of sexual risk propensity score

    Measured: Baseline, 6, 12, 18, and 24 months

  5. HIV risk behavior during PrEP use, unprotected sex

    Proportions of participants reporting unprotected vaginal or anal sex in the prior 30 days

    Measured: Baseline, 6, 12, 18, and 24 months

  6. Feasibility of PS and RRT interventions, intervention delivery

    Proportion of expected intervention sessions delivered

    Measured: 24 months

  7. Feasibility of PS and RRT interventions, study visit retention

    Proportion of participants retained at each study visit

    Measured: 24 months

  8. Completion of study visits between PS and RRT

    Proportion who completed scheduled PrEP study visits in PS and RRT arms at 18 and 24 months compared to proportion who completed these study visits at 12 months

    Measured: 12, 18 and 24 months

  9. Scaled perception of PrEP, PS and RRT

    Scaled perceptions of satisfaction with and utility of PS and RRT intervention components, PrEP, and clinical care

    Measured: 24 months

  10. Safety of PrEP including social harms

    Discontinuation rates of PrEP due to an AE or drug toxicity and occurrence of social harms

    Measured: 24 months

  11. Discontinuation of PrEP

    Discontinuation rates of PrEP due to situational changes, dislike of PrEP

    Measured: 24 months

Timeline

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

  1. First posted17 Jun 2019
  2. Study start31 Oct 2019
  3. Primary completion10 Mar 2022
  4. Study completion10 Mar 2022

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03988387
Sponsor's protocol ID
AAAS3722
Other IDs
R01MH110051
Status last verified
Sep 2022
First submitted
12 Jun 2019
Last updated
29 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Peer Support (PS), Reminder and Resource Transfer (RRT) and daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] in people with HIV, run by Columbia University at 1 site in Kenya.

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 4 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 29 Sep 2022. 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 Kenya. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Adherence between PS and RRT arms (time frame: 12 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 NCT03988387.

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 29 Sep 2022.

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