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Completed

NCT Number: NCT04408729

PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and two focus group discussions (with up to 5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). The investigators will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). The study team will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Kisumu, Kenya

About this study

  • Develop PrEP My Way. Using a client-centered approach, the study team will iteratively conduct individual interviews and focus group discussions with up to 25 Kenyan women (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and peer delivery system (including phone communication and kit delivery plans).
  • Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. The investigators will randomize 100 Kenyan women (age 16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 and 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation) per Kenyan national guidelines [39]) or 16-17 year-olds with parental consent
  • Reported sexual activity within the past 3 months
  • Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1)
  • Residence in the Kisumu region
  • Phone ownership
  • Ability to understand KiSwahili, DhoLuo, and/or English

Exclusion criteria

  • Inability to provide informed consent (e.g., intoxication, mental disability)

Treatment and study plan

PrEP My Way

Other

Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).

This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP.

Primary outcomes

  1. PrEP Adherence

    Time frame: Six months

    PrEP adherence as measured by detectable tenofovir-diphosphate (TFV-DP) in dried blood spots

Secondary outcomes

  1. Self-reported PrEP Adherence in the Past 30 Days

    Time frame: Months 1, 3, 6 (intervention arm)

    PrEP adherence as measured by questionnaires at kit delivery.

  2. Number of Participants With PrEP Persistence (Kit Delivery/Pharmacy Refill)

    Time frame: At 6 months

    PrEP use as measured by PrEP receipt in the kit (intervention) or pharmacy pick up (control) at 6 months

  3. Rates of STI Testing

    Time frame: Months 1, 3, and 6

    Testing for gonorrhea and chlamydia

  4. Rates of Hormonal Contraception

    Time frame: Months 1, 3, and 6

    Receipt of oral contraceptive pills or injections of medroxyprogesterone at least once among participants not using long-acting contraception (i.e., contraceptive implants or intrauterine devices)

  5. Prevention-effective Adherence at 6 Months

    Time frame: Measured at 6 months

    Detectable TFV-DP among women with ongoing HIV prevention needs, defined as meeting one or more of the following criteria: 1) PrEP use (per self-report and/or detectable TFVp-DP), 2) >1 concurrent sexual partner, 3) condomless sex, and 4) indication of "some/a lot of concern about getting HIV)

Other outcomes

  1. Feasibility of Intervention Use

    Time frame: Six months

    The PrEP My Way intervention will be considered feasible if >70% (35/50) participants 1) receive a kit at Months 1, 3, and 6; and 2) have a readable HIV test, usable vaginal swab, and self-injection of medroxyprogesterone, if desired, per protocol at >66% (2/3) of visits. The outcome indicates the number of participants at each time point who received a kit and were able to 1) read their HIV test (if testing was desired), 2) provide a vaginal swab that could be assessed for gonorrhea/chlamydia (if testing was desired), and 3) inject medroxyprogesterone (if the product was desired).

  2. Acceptability of Intervention

    Time frame: Six months

    The PrEP My Way intervention will be considered acceptable if >70% (35/50) participants rate 70% (7/10) items on the Systems Usability Scale (SUS) as "very good" or higher. The scores on the SUS are normalized on a scale 0-100 (higher scores indicate higher usability).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Emory University
  • Kenya Medical Research Institute

Registry information

Official study title

"PrEP My Way": A Novel PrEP Delivery System to Meet the Needs of Young African Women

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 29, 2020
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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