PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya

NCT05465265 | Completed DMC

• 2 other identifiers: STUDY000137013D43TW009345-10S6
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators broadly aim at determining barriers and facilitators to PrEP uptake and adherence and retention among the study participants. The investigators have the following specific objectives of determining: (1) the PrEP knowledge levels, attitudes, practices, and user experiences among injecting and sexual partners of PWID in Nairobi County (2) the socio-demographic, behavioural, and structural factors hindering the uptake of PrEP among PWID's sexual and injecting partners in Nairobi County; and (3) the effect of a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation on the uptake of PrEP by the study participants. The investigators hypothesize that: PWID's injecting and sexual partners in Nairobi City lack PrEP knowledge, and have poor attitudes practices, and user experiences about PrEP; less than 50.0% of the PWID's sexual and injecting partners in Nairobi County have socio-demographic, behavioural and structural factors hindering their uptake of PrEP; and a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation has no effect on the uptake of PrEP by the study participants.

Conditions

HIV Antibody Positivity; PrEP Uptake

Outcome Measures

Primary Outcomes (3)

• PrEP uptake following either navigation or provision of pamphlets (Self-reported uptake reported through quantitative interviews)

  Outcome 1: Uptake of PrEP following the study interventions (either navigation into PrEP or pamphlets) Outcome 2-Adherence to PrEP Outcome 3: Retention into PrEP following uptake

  12 weeks

• Retention into PrEP after uptake following either navigation or provision of pamphlets (Self-reported retention)

  Retention into PrEP for 18 weeks (self-reported through interviews conducted by investigators))

  18 weeks

• Adherence to PrEP for 18 weeks (self reported through interviews conducted by investigators)

  Adherence to PrEP after uptake following either navigation or provision of pamphlets (Self-reported adherence through interviews conducted by investigators)

  18 weeks

Secondary Outcomes (1)

• HIV Status following Rapid HIV tests OraQuick rapid HIV 1 antibody tests

  18 weeks

Study Arms (2)

Intervention and control group

ACTIVE COMPARATOR

To establish the effect of navigation on PrEP uptake, adherence and retention among PWID.

Behavioral: Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)

Control group

PLACEBO COMPARATOR

To establish the effect of providing PrEP information through pamphlets on PrEP uptake, adherence and retention among PWID.

Behavioral: Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)

Interventions

Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs) BEHAVIORAL

Cases: Navigation of PWID into PrEP-Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs) Control group: Provision of PrEP information to PWID through pamphlets on PrEP uptake, adherence and retention among PWID.

Also known as: Control Group: Provision of PrEP pamphlets has is expected to have no effect on uptake of PrEP, adherence to PrEP and retention into PrEP

Control group; Intervention and control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being age 18 years and above.
• Being HIV negative on a rapid HIV test conducted prior to interviews.
• No pregnancy for females at the time of recruitment.
• Active injection of illicit drugs in the six months preceding the study.
• High multiple HIV risk and high HIV through sexual activities and sharing of injection equipment or syringes (the high multiple-risk group mixed unsafe drug use with unsafe sexual practices; the second group practiced high-risk sex with non-consistent condom combined with drug use; the moderate-risk group had limited unsafe sexual practices; and the "low-risk" group never had unprotected sex and never shared needles and other injection equipment).
• Informed consent to participate inti the study.

You may not qualify if:

• Being a minor (below 18 years).
• Those not actively injecting drugs.
• Acute or chronic HIV infection
• Those not consenting to participation into the study.
• Pregnancy.

Sponsors & Collaborators

• University of Washington: lead
• Kenyatta National Hospital: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Pangani DIC, Ngara DIC, Githurai DIC, Kawangware DIC

Nairobi, Nairobi County, 254, Kenya

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Cosmas Gitobu

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Cases : Navigation into PrEP Control group: Provision of pamphlets with information on PrEP.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator as a Post doctoral fellowship candidate, University of Washington

Model Details: The study may have two arms: "Cases will be navigated into PrEP services" and the "Control group will just be given PrEP information pamphlets"

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 19, 2022
• Study Start: September 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

KE (1)