Pharmacy and Poisons Board: Applications

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Protocol No:

ECCT/21/08/02

Date of Protocol:

20-05-2021

Study Title:

IPrEP Men’s Study: Expanding the reach of prevention for men in Kisumu, Kenya

Study Objectives:

Table 1. Study Objectives and Outcome Definitions

Study Objectives

Outcome Definitions

Primary

Measure PrEP adherence at 6 months

% of participants with plasma tenofovir concentration of >40 ng/mL (consistent with daily adherence) at 6-month visit (primary outcome) ⁴³

Secondary

Measure PrEP adherence at 3 months

% of participants with plasma tenofovir concentration of >40 ng/mL at 3 month visit

Determine detectable ARV at 3 and 6 months

% of participants with detectable ARV (i.e, plasma tenofovir concentration of >0.31 ng/ml) at 3- and 6-month visit

% of participants with inconsistent adherence (i.e, plasma tenofovir concentration between 0.31 and 40 ng/ml) at 3- and 6-month visit

Determine self-reported adherence

% who self-report daily adherence in the past 7 days (no doses missed)

Determine completion of study visits at 3 and 6 months

% who completed scheduled PrEP+ study visits at 3 and 6 months

Determine acceptability of urine drug-level assay as objective measure of recent PrEP adherence

Scaled perceptions of acceptability of urine drug level as a measure of recent PrEP adherence

Determine acceptability of feedback and counseling based on urine drug-level assay results

Scaled perceptions of satisfaction with feedback and counseling

Compare PrEP adherence measured by blood plasma and urine drug-level assays

Concordance and correlation of drug levels among blood plasma and urine-drug levels to measure PrEP adherence

Evaluate sexual risk behavior while taking PrEP

% of MC reporting unprotected vaginal or anal sex in the prior 30 days at baseline, and 1, 3 and 6 months with paid (commercial) and non-paying sexual partners

Median number of sexual partners that MC PrEP users have in past 3 months

Assess whether adherence to PrEP is associated with sexual risk behavior

Association of adherence to PrEP by self-report with sexual risk behavior

Determine acceptability of daily oral PrEP

MC perceptions of and experience with PrEP+ strategy;

Challenges faced

Determine feasibility of recruiting MC in PrEP+ intervention

% of men approached accepting screening; % of those screened who are eligible; % of those eligible enrolled.

Ability to recruit MC in PrEP+ intervention.

Determine feasibility of retaining MCs in PrEP+ intervention

% of MCs retained at 3 and 6 months.

Pre-post comparison will be made with regard to risk behaviors.

# and type of retention efforts needed to support retention over study duration

Determine feasibility of PrEP+ strategy to determine whether future testing is warranted

% of PrEP+ intervention implemented as planned

Determine use and acceptability of HIVST to confirm HIV status while taking PrEP

% of test kits distributed used.

Standardized format to record HIVST use

Determine number of new HIV infections (descriptive purposes)

% of participants self-reporting reactive test result via HIV ST kit

# of participants self-reporting reactive test result via HIV ST kit with a confirmatory HIV positive test at follow-up visits.

Assess social harms associated with PrEP use

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

Laymans Summary:

This is a prospective cohort study in which HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovir [FTC/TDF]) combined with two adherence self-management interventions: (1) real-time feedback from POC urine drug-level assay, (2) HIVST and (3) 2-way text message reminders.

Potential MC participants will be recruited from pre-specified community-based venues (“hotspots”) or through referral by FSW using convenience sampling. Potential participants will be prescreened for age; residence and intent to stay in Kisumu for study duration, and having exchanged money, goods, or services for sex with a woman in the past three months. Individuals who meet prescreening eligibility criteria will be invited to the study site to undergo informed consenting process. Consenting individuals will complete a baseline questionnaire and then undergo HIV counseling and testing as per national guidelines. Participants found to be HIV-positive will receive appropriate post-test counseling, including referral for immediate HIV treatment initiation at local health facility providing HIV care and treatment services. They will be compensated for the visit and informed that they will not have further study follow-up except to confirm that the referral was completed. Participants with negative HIV test results will complete eligibility screening for PrEP as per national guidelines. Eligible individuals will be prescribed once-daily oral PrEP, undergo HIV risk-reduction counseling session and receive HIVST kits for use between study visits. Participants who are not eligible for PrEP will be compensated for the visit and informed that they will not have further study follow-up. Enrollment will end when 120 HIV-negative MC eligible and willing to start PrEP are enrolled into the cohort.

Study participants will have a baseline visit, will be followed for a total of 6 months and attend 3 study visits over this period (1 month, 3 months and 6 months). At each follow-up visit, participants will undergo HIV rapid testing; screening for adverse events, sexually transmitted infections (STIs) and acute HIV infection; a focused clinical exam, urine and blood specimen collection; receive HIV risk-reduction counseling (as per national guidelines), PrEP prescription refills and tailored adherence self-management counseling and HIVST kits; and complete study questionnaires.

This trial will be conducted in Kisumu County.

Abstract of Study:

Purpose:	The purpose of this study is to assess adherence, feasibility, and acceptability of PrEP+, an experimental pre-exposure prophylaxis (PrEP)-focused prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with two adherence self-management interventions: (1) real-time feedback from point-of-care urine drug-level assay, (2) HIV self-testing and (3) 2-way text message reminders in addition to standard of care HIV risk-reduction counseling among male clients (MC) of female sex workers in Kisumu, Kenya.
Study Objectives:	Primary Objective Assess PrEP adherence 6-months Secondary Objectives Assess PrEP adherence at 3-months Determine completion of study visits at 3 and 6 months Evaluate sexual risk behavior while taking PrEP Determine acceptability of daily oral PrEP Determine acceptability of urine drug-level assay as objective measure of recent PrEP adherence Determine acceptability of feedback and counseling based on urine drug-level assay results Determine feasibility, use and acceptability of HIVST to confirm HIV status while taking PrEP Assess association between PrEP adherence and sexual risk behavior Determine number of new HIV infections (for descriptive purposes only) Assess social harms associated with PrEP use Determine feasibility of recruiting MCs into PrEP+ intervention Determine feasibility of retaining MCs in PrEP+ intervention over a 6-month period
Design:	Prospective cohort study
Study Population:	HIV-negative male clients of female sex workers
Study Size:	N= 200 (HIV testing); N= 120 (MC cohort)
Study Duration:	Enrollment period is 3 months. All MC participants will be followed for 6 months.