HIV/AIDSMPYANCT02915367

Monitoring Pre-exposure Prophylaxis for Young Adult Women

A study testing SMS Reminders in people with HIV/AIDS and Adherence, run by Massachusetts General Hospital at 2 sites 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

Next generation real-time monitoring for PrEP adherence in young Kenyan women 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/AIDS, Adherence
What is being tested?: SMS Reminders
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 348 participants
Where: 2 sitesKenya
Study dates: 21 Dec 2016to 30 Apr 2020
Phase: Interventional
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 to 24 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

HIV-uninfected (as determined by Kenya national testing algorithms)
Wanting to start PrEP with an initial recommendation of 6 months of use
Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:
Creatinine clearance >60 mL/min
Not infected with hepatitis B
No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study

Show all 13Show fewer

Sexually active (defined as vaginal or anal sex) within the last 3 months
At high risk for HIV infection based on a validated risk score of >5 or being in an HIV serodiscordant relationship
Not pregnant
Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it
Ability to send a text message
Intending to stay in the area for at least the next year
Willing to use study criteria

Who cannot join

Unable to provide consent
Breast-feeding (PrEPis not currently approved for use during breast-feeding)
Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

KEMRI
Kisumu
KEMRI
Thika

Other trials in Kenya

About this study

Official title: Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women

Next generation real-time monitoring for PrEP adherence in young Kenyan women

Read the detailed description

This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.

Conditions: HIV/AIDS, Adherence
Being tested: SMS Reminders
Keywords: HIV/AIDS, adherence, women, real time monitoring, risk, SMS, mHealth
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

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

SMS RemindersBehavioural
Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).

Study groups in NCT02915367
Study group	Role	What they receive
SMS Reminders	Experimental	Participants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device. Receives: Behavioral: SMS Reminders
No Reminders	No intervention	Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.

What is being measured

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

Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
Measured: up to 2 years follow-up

Secondary outcomes (2)

Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
Questionnaire indicating "very interested" in using the Wisepill monitor (a pill box that records the date and time of each opening as a proxy for pill ingestion)
Measured: Month 1
USD Per Month
Cost estimates (including time and motion studies) and mathematical modeling estimate the cost-effectiveness of Wisepill plus SMS reminders per HIV case averted
Measured: two years

Timeline

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

21 Dec 201630 Apr 2020

First posted27 Sep 2016 (estimated)
Study start21 Dec 2016
Primary completion20 Mar 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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 N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 348 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02915367
Sponsor's protocol ID: R01MH109309
Acronym: MPYA
Status last verified: Apr 2023
First submitted: 16 Sep 2016
Last updated: 31 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified data will be made available at the end of the study upon request.

Publications

Haberer JE, Mugo N, Bukusi EA, Ngure K, Kiptinness C, Oware K, Garrison LE, Musinguzi N, Pyra M, Valenzuela S, Thomas KK, Anderson PL, Thirumurthy H, Baeten JM. Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):251-260. doi: 10.1097/QAI.0000000000002876.
PubMed 35147580
Haberer JE, Bukusi EA, Mugo NR, Pyra M, Kiptinness C, Oware K, Garrison LE, Thomas KK, Musinguzi N, Morrison S, Anderson PL, Ngure K, Baeten JM; MPYA Study Team. Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial. Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6.
PubMed 33662265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
ClinicalTrials.gov ID: NCT02915367
Acronym / sponsor ID: MPYA / R01MH109309
Conditions: HIV/AIDS, Adherence
Keywords: HIV/AIDS, adherence, women, real time monitoring, risk, SMS, mHealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 348 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: University of Washington, Kenya Medical Research Institute
Study start: 21 Dec 2016 (actual)
Primary completion: 20 Mar 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 27 Sep 2016 (estimated)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Next generation real-time monitoring for PrEP adherence in young Kenyan women

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SMS Reminders	Experimental	Behavioral: SMS RemindersParticipants will receive regular SMS reminders regarding PrEP. All participants will receive adherence monitoring through a WisePill device.
No Reminders	No intervention	–Participants will not receive SMS reminders. All participants will receive adherence monitoring through a WisePill device.

Who may qualify

Ages: 18 to 24 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

HIV-uninfected (as determined by Kenya national testing algorithms)
Wanting to start PrEP with an initial recommendation of 6 months of use
Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:
Sexually active (defined as vaginal or anal sex) within the last 3 months
At high risk for HIV infection based on a validated risk score of >5 or being in an HIV serodiscordant relationship

Key exclusion criteria (3 listed)

Unable to provide consent
Breast-feeding (PrEPis not currently approved for use during breast-feeding)
Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.

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
SMS RemindersParticipants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).	Behavioural	SMS Reminders

Primary outcome

Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
Time frame: up to 2 years follow-up
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.

2 secondary outcomes

Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring
Time frame: Month 1
USD Per Month
Time frame: two years

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SMS Reminders	173	136
No Reminders	175	144

Primary outcome: Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months

Time frame: up to 2 years follow-up. Mean (95% Confidence Interval). Unit: percentage of adherence

Measure	SMS Reminders n = 173	No Reminders n = 175
Month 6 adherence	40.2 (36.1 to 44.4)	36.8 (32.7 to 40.8)
Month 24 adherence	27.0 (23.6 to 30.5)	26.6 (23.1 to 30.2)

Population analysed: Number of participants choosing to take PrEP per arm

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: We attempted to follow all participants for 24 months.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SMS Reminders	0 of 173 (0%)	5 of 173 (2.9%)	1 of 173
No Reminders	0 of 174 (0%)	5 of 174 (2.9%)	0 of 175

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35147580Haberer JE, Mugo N, Bukusi EA, Ngure K, Kiptinness C, Oware K, Garrison LE, Musinguzi N, Pyra M, Valenzuela S, Thomas KK, Anderson PL, Thirumurthy H, Baeten JM. Understanding Pre-Exposure Prophylaxis Adherence in Young Women in Kenya. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):251-260. doi: 10.1097/QAI.0000000000002876.
Derived from this study: PubMed 33662265Haberer JE, Bukusi EA, Mugo NR, Pyra M, Kiptinness C, Oware K, Garrison LE, Thomas KK, Musinguzi N, Morrison S, Anderson PL, Ngure K, Baeten JM; MPYA Study Team. Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial. Lancet HIV. 2021 Mar;8(3):e130-e137. doi: 10.1016/S2352-3018(20)30307-6.
Individual participant dataSharing planned: Yes. De-identified data will be made available at the end of the study upon request.

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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.

Jessica Haberer, MD, MS principal investigator

Massachussetts General Hospital

Jared Baeten, MD, PhD principal investigator

University of Washington

Nelly Mugo study director

Kenya Medical Research Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SMS Reminders in people with HIV/AIDS and Adherence, run by Massachusetts General Hospital at 2 sites 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 13 inclusion and 3 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 31 May 2023. 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 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?

Yes. Results are posted in the registry (first posted 8 Apr 2022). 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?

Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months (time frame: up to 2 years follow-up). 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 NCT02915367, which also lists 2 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 31 May 2023.