HIV Antibody PositivityNCT05465265
PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya
A study testing Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs) in people with HIV Antibody Positivity and PrEP Uptake, run by University of Washington at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Antibody Positivity, PrEP Uptake
- What is being tested?
- Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteKenya
- Study dates
- 1 Sep 2021to 30 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria for the study includes:
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.
The exclusion criteria includes:
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.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Pangani DIC, Ngara DIC, Githurai DIC, Kawangware DIC
Nairobi, Nairobi County, 254
About this study
Official title: Pre-Exposure Prophylaxis for Prevention of Human Immunodeficiency Virus Transmission Among Sexual and Injecting Partners of People Who Inject Drugs in Nairobi, Kenya
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.
Read the detailed description
Background: The annual global number of new HIV infections among adults has remained unchanged over the last decade and it is largely fuelled by key populations among them people who inject drugs (PWID). Key populations in Kenya account for one-third of all new HIV infections and 18.3% of PWID in the country are living with HIV. Drug and substance use is on the increase in the country, with close to 4 out of 10 Kenyans reporting to have used a substance in their lifetime including injectable drugs thus fueling the spread of HIV. Pre-Exposure Prophylaxis (PrEP) is effective in the prevention of HIV transmission among PWID by over 70.0% if and when used correctly. However, uptake, adherence, scale-up of use, coverage and retention currently remain limited. Thus, effective interventions are needed to enhance the uptake of PrEP among PWID and their sexual and injecting partners in order to prevent HIV transmission.
Objectives of the Study: Broadly, the investigators aim at determining PrEP uptake barriers and facilitators and adherence among the study participants and the sequel of a theory-guided behavioral intervention model (PrEP-UP) on the uptake of PrEP by the study participants. Specifically, the investigators aim at determining: (1) the PrEP knowledge levels, attitudes, practices and user experiences among the study participants(2) the socio-demographic, behavioural and structural factors hindering the uptake of PrEP among the study participants; 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.
Methods: The investigators will conduct the study for twelve months (1st July 2021 to 30th June 2022) and they will use an implementation study through a pre-post design to assess 256 participants' self-reported PrEP uptake and retention before and after exposure to a theory-guided behavioural intervention (PrEP-UP) utilizing navigators and peer outreach for the 128 'cases' and PrEP information Pamphlet and list of health facilities offering PrEP for free in Nairobi County for the 128 'control' group members. The investigators will use four study sites namely Githurai, Kawangware, Ngara and Pangani PWID's hotspots within Nairobi City. The targeted study participants are PWID's sexual and injecting partners of ages 18 years and above. The investigators will recruit 256 study participants into the study by use of peers and social workers in the University of Washington's Needle and Syringe Program (NSP) sites in Githurai, Kawangware, Ngara and Pangani. The investigators will collect baseline data after recruitment while the interventions for both groups will be offered in a maximum 5 contact sessions with investigators and a follow-up of the participants will be done by the investigators at weeks 4, 8 and 12 to establish whether study participants have taken up PrEP by week 12 during which post-intervention data will be collected. Lastly, participants' self-reported PrEP retention will be documented by investigators at 18 weeks and HIV tests will be conducted on the participants by the investigators (optional) through OraQuick antibody HIV tests. The investigators will analyze: quantitative data through the Statistical Package for Social Sciences (SPSS) version 24 and: qualitative data through flow chart matrices to establish divergence and convergence of themes.
Significance of the Study: Through the study, the investigators will contribute to the global call for the reduction in new HIV infections among PWIDs and their sexual and injecting partners. The study will further inform the investigators on the effectiveness-implementation science interventions and recommend the best PrEP scale-up approaches in addition to contributing to the global scientific knowledge.
- Conditions
- HIV Antibody Positivity, PrEP Uptake
- Being tested
- Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)Behavioural
Also called Control Group: Provision of PrEP pamphlets has is expected to have no effect on uptake of PrEP, adherence to PrEP and retention into PrEP
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention and control group | Active comparator | To establish the effect of navigation on PrEP uptake, adherence and retention among PWID. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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))
Measured: 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)
Measured: 18 weeks
Secondary outcomes (1)
HIV Status following Rapid HIV tests OraQuick rapid HIV 1 antibody tests
Seroconversion following PreP uptake or failure to take up PrEP in the 18 weeks of the RCT
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Sep 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Antibody PositivityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Model description
- The study may have two arms: "Cases will be navigated into PrEP services" and the "Control group will just be given PrEP information pamphlets"
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Cosmas Gitobu, University of Washington
- Investigators
- Cosmas Gitobu, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465265
- Sponsor's protocol ID
- STUDY00013701
- Other IDs
- 3D43TW009345-10S6
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Exposure Prophylaxis for Prevention of Human Immunodeficiency Virus Transmission Among Sexual and Injecting Partners of People Who Inject Drugs in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT05465265
- Acronym / sponsor ID
- STUDY00013701
- Conditions
- HIV Antibody Positivity, PrEP Uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, Fogarty International Center of the National Institute of Health
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The annual global number of new HIV infections among adults has remained unchanged over the last decade and it is largely fuelled by key populations among them people who inject drugs (PWID). Key populations in Kenya account for one-third of all new HIV infections and 18.3% of PWID in the country are living with HIV. Drug and substance use is on the increase in the country, with close to 4 out of 10 Kenyans reporting to have used a substance in their lifetime including injectable drugs thus fueling the spread of HIV. Pre-Exposure Prophylaxis (PrEP) is effective in the prevention of HIV transmission among PWID by over 70.0% if and when used correctly. However, uptake, adherence, scale-up of use, coverage and retention currently remain limited. Thus, effective interventions are needed to enhance the uptake of PrEP among PWID and their sexual and injecting partners in order to prevent HIV transmission.
Objectives of the Study: Broadly, the investigators aim at determining PrEP uptake barriers and facilitators and adherence among the study participants and the sequel of a theory-guided behavioral intervention model (PrEP-UP) on the uptake of PrEP by the study participants. Specifically, the investigators aim at determining: (1) the PrEP knowledge levels, attitudes, practices and user experiences among the study participants(2) the socio-demographic, behavioural and structural factors hindering the uptake of PrEP among the study participants; 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.
Methods: The investigators will conduct the study for twelve months (1st July 2021 to 30th June 2022) and they will use an implementation study through a pre-post design to assess 256 participants' self-reported PrEP uptake and retention before and after exposure to a theory-guided behavioural intervention (PrEP-UP) utilizing navigators and peer outreach for the 128 'cases' and PrEP information Pamphlet and list of health facilities offering PrEP for free in Nairobi County for the 128 'control' group members. The investigators will use four study sites namely Githurai, Kawangware, Ngara and Pangani PWID's hotspots within Nairobi City. The targeted study participants are PWID's sexual and injecting partners of ages 18 years and above. The investigators will recruit 256 study participants into the study by use of peers and social workers in the University of Washington's Needle and Syringe Program (NSP) sites in Githurai, Kawangware, Ngara and Pangani. The investigators will collect baseline data after recruitment while the interventions for both groups will be offered in a maximum 5 contact sessions with investigators and a follow-up of the participants will be done by the investigators at weeks 4, 8 and 12 to establish whether study participants have taken up PrEP by week 12 during which post-intervention data will be collected. Lastly, participants' self-reported PrEP retention will be documented by investigators at 18 weeks and HIV tests will be conducted on the participants by the investigators (optional) through OraQuick antibody HIV tests. The investigators will analyze: quantitative data through the Statistical Package for Social Sciences (SPSS) version 24 and: qualitative data through flow chart matrices to establish divergence and convergence of themes.
Significance of the Study: Through the study, the investigators will contribute to the global call for the reduction in new HIV infections among PWIDs and their sexual and injecting partners. The study will further inform the investigators on the effectiveness-implementation science interventions and recommend the best PrEP scale-up approaches in addition to contributing to the global scientific knowledge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The study may have two arms: "Cases will be navigated into PrEP services" and the "Control group will just be given PrEP information pamphlets"
| Arm | Type | Receives |
|---|---|---|
| Intervention and control group | Active comparator | 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)To establish the effect of navigation on PrEP uptake, adherence and retention among PWID. |
| Control group | Placebo comparator | 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)To establish the effect of providing PrEP information through pamphlets on PrEP uptake, adherence and retention among PWID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)Also: Control Group: Provision of PrEP pamphlets has is expected to have no effect on uptake of PrEP, adherence to PrEP and retention into PrEPCases: 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. | Behavioural | Control group, Intervention and control group |
Primary outcome
PrEP uptake following either navigation or provision of pamphlets (Self-reported uptake reported through quantitative interviews)
Time frame: 12 weeks
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
Retention into PrEP after uptake following either navigation or provision of pamphlets (Self-reported retention)
Time frame: 18 weeks
Retention into PrEP for 18 weeks (self-reported through interviews conducted by investigators))
Adherence to PrEP for 18 weeks (self reported through interviews conducted by investigators)
Time frame: 18 weeks
Adherence to PrEP after uptake following either navigation or provision of pamphlets (Self-reported adherence through interviews conducted by investigators)
1 secondary outcome
HIV Status following Rapid HIV tests OraQuick rapid HIV 1 antibody tests
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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.
Cosmas Gitobu principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs) in people with HIV Antibody Positivity and PrEP Uptake, run by University of Washington 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?
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 4 Apr 2025. 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. Some participants in this study may receive a placebo. 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 uptake following either navigation or provision of pamphlets (Self-reported uptake reported through quantitative interviews) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.