HIV/AIDSNCT04044235
Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women
A study testing PrEP Cohort in people with HIV/AIDS, run by Lighthouse Trust at 2 sites in Malawi.
Trial summary
To provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facilities in Lilongwe, Malawi. 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
- What is being tested?
- PrEP Cohort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,032 participants
- Where
- 2 sitesMalawi
- Study dates
- 25 Jun 2019to 24 Dec 2020
- 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 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligibility criteria for the cross-sectional study
- Female
- Consent to be counselled and tested for HIV
- Between 18 and 24 years old
- Ongoing HIV risk according to the risk Assessment guide
- Participated in the cross-sectional screening study or meets the eligibility criteria for the cross-sectional study
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- Willing to provide written informed consent to participate in the HIV incidence study
- Accesses services at a mobile or fixed clinic in the defined catchment area
- Not planning to relocate in the next 12 months Eligibility criteria for the prospective PrEP for AGYW
- Participated in the cross-sectional study
- HIV-negative
- Answers yes to any two questions from the PrEP screening tool
- Willing and able to adhere to daily PrEP
- Willing to provide written informed consent to participate in the PrEP study
- Accesses services at a mobile or fixed clinic in the defined catchment area
- Not planning to relocate in the next 12 months
- Eligibility criteria for focus group discussions for PrEP providers
- Provided PrEP for at least 3 months
- Trained nurse
- Orientated in PrEP and study procedures
Who cannot join
- HIV positive
- Under 18 years or older than 24 years at enrollment (including AGYW aged 24 years at enrolment)
- Breastfeeding women
- Already taking oral or injectable PrEP through another study
- Current or past history of renal or liver disease
- Clients on multi-drug resistant tuberculosis (MDR-TB) medications
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- Signs of acute HIV infection. The client would be asked to return after 3 months for a re-evaluation
- FSW <35kg
- Known allergy to tenofovir disoproxil fumarate (TDF) and/or emtricitabine (FTC);
- Unwilling or unable to return for 3-monthly HIV testing, counselling and safety monitoring visits or planning to relocate to another geographic area during the period of the study.
- Blood creatinine clearance (Cr Cl) <60ml/min
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites, 2 recruiting
- Recruiting
Bwaila Hospital
Lilongwe, Central Region
- Recruiting
Kawale Health Centre
Lilongwe, Central Region
About this study
Official title: HIV Incidence in a Cohort of and Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women in Urban Lilongwe, Central Malawi
To provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facilities in Lilongwe, Malawi. The primary objective of the study is to assess the feasibility, acceptability, tolerability and cost of delivering PrEP among high-risk AGYW aged 18-24 years and healthcare providers in urban Lilongwe. Secondary objectives are (i) to assess the program's ability to enroll and retain a PrEP cohort for one year and (ii) measure the incidence of HIV infection among high risk AGYW in urban Lilongwe among women who decline to enroll in the PrEP study (these will be offered enrollment in the HIV incidence study).
Read the detailed description
The main goal of the study is to provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facilities in Lilongwe, Malawi. The primary objectives are to; determine HIV prevalence among all AGYW identified as potentially at high risk of HIV infection in urban Lilongwe; assess the HIV program's ability to enroll and retain the PrEP cohort for one year; assess participants' and providers' perceptions of the barriers and facilitators for providing PrEP to inform implementation of PrEP study and future interventions and assess the cost of PrEP delivery in the routine HIV program.
Secondary Objectives:
- To measure annual HIV incidence in a prospective cohort of HIV-negative AGYW identified as potentially at high risk of HIV infection but declined to enroll in PrEP cohort study in urban Lilongwe.
- To measure annual HIV incidence among HIV-negative AGYW who enrolled in PrEP cohort study in urban Lilongwe.
- To determine risk factors for HIV in a cohort of AGYW recruited in the prospective cohort study
- Conditions
- HIV/AIDS
- Being tested
- PrEP Cohort
- 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.
PrEP CohortBehavioural
AGYW who are eligible for PrEP will be educated about the risk and benefits. For AGYW (aged 18-24 years) who consent to PrEP, an ART provider (nurse or clinician) certified by the MOH will provide PrEP (package of disoproxil fumarate/emtricitabine (Truvada)) on the same day that the client is determined eligible. Peer navigators will ensure linkage to facilities for follow-up care. The initial follow-up visit will occur one month from PrEP initiation to ensure that the client is tolerating the regimen and to answer any questions, with three-month follow-up visits thereafter.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Cohort | Experimental | AGYW HIV-negative and established to be at high risk will be consented to enroll in the PrEP study. AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW. Receives: Behavioral: PrEP Cohort |
| HIV Incidence | No intervention | HIV Incidence Cohort: In the second component, AGYW who refuse PrEP will be consented to enroll in an HIV incidence cohort study and will be followed every 3 months for 12 months to determine HIV incidence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Proportion of participants by risk group and age enrollment who are retained at 3, 6, 9, 12 months after enrollment in each study arm
Measured: 12 Months
HIV Incidence
Proportion of participants newly diagnosed HIV positive at 3, 6, 9, 12 months after enrollment in each study arm
Measured: 12 Months
Secondary outcomes (2)
Follow-up outcomes
Number of participants by follow-up outcomes ( Discontinue, dead, withdraw, lost to follow-up) for each study arm
Measured: 12 months
Uptake
Number of clients enrolled in each study arm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start25 Jun 2019
- Primary completion24 Dec 2020 (estimated)
- Study completion24 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non- randomized study design being implemented in 2 facilities in Lilongwe Urban. The first component is a cross-sectional study of AGYW in which HIV testing counselors will offer HIV tests and assess HIV risk. A sample of AGYW testing HIV-negative and established to be at high risk will be consented to enroll in the PrEP study. In the second component, AGYW who refuse PrEP will be consented to enroll in an HIV incidence cohort study and will be followed every 3 months for 12 months to determine HIV incidence. In the third component, AGYW who consent will be enrolled in a PrEP study. The PrEP study has two phases, which are, (i) a formative qualitative study involving AGYW and PrEP providers to understand factors and barriers to delivering PrEP to AGYW and (ii) a feasibility study of delivering PrEP to HIV negative AGYW. AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lighthouse Trust
- Sponsor type
- University, hospital or other
- Collaborators
- United States President's Emergency Plan for AIDS Relief, Ministry of Health, Malawi, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Sam Phiri, PhD, MSc, DCM, Lighthouse Trust
- Investigators
- Sam Phiri, PhD, Principal investigator, Lighthouse Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044235
- Sponsor's protocol ID
- PrEP
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Incidence in a Cohort of and Evaluation of Pre-Exposure Prophylaxis for High Risk Adolescent Girls and Young Women in Urban Lilongwe, Central Malawi
- ClinicalTrials.gov ID
- NCT04044235
- Acronym / sponsor ID
- PrEP
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,032 participants (estimated)
- Lead sponsor
- Lighthouse TrustUniversity, hospital or other
- Collaborators
- United States President's Emergency Plan for AIDS Relief, Ministry of Health, Malawi, Centers for Disease Control and Prevention
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 24 Dec 2020 (estimated)
- Study completion
- 24 Dec 2020 (estimated)
- First posted
- 5 Aug 2019 (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.
To provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facilities in Lilongwe, Malawi. The primary objective of the study is to assess the feasibility, acceptability, tolerability and cost of delivering PrEP among high-risk AGYW aged 18-24 years and healthcare providers in urban Lilongwe. Secondary objectives are (i) to assess the program's ability to enroll and retain a PrEP cohort for one year and (ii) measure the incidence of HIV infection among high risk AGYW in urban Lilongwe among women who decline to enroll in the PrEP study (these will be offered enrollment in the HIV incidence study).
Detailed description
The main goal of the study is to provide preliminary evidence about feasibility and acceptability of delivering PrEP to AGYW identified as potentially at high risk of HIV infection in Lilongwe city communities and two public facilities in Lilongwe, Malawi. The primary objectives are to; determine HIV prevalence among all AGYW identified as potentially at high risk of HIV infection in urban Lilongwe; assess the HIV program's ability to enroll and retain the PrEP cohort for one year; assess participants' and providers' perceptions of the barriers and facilitators for providing PrEP to inform implementation of PrEP study and future interventions and assess the cost of PrEP delivery in the routine HIV program.
Secondary Objectives:
- To measure annual HIV incidence in a prospective cohort of HIV-negative AGYW identified as potentially at high risk of HIV infection but declined to enroll in PrEP cohort study in urban Lilongwe.
- To measure annual HIV incidence among HIV-negative AGYW who enrolled in PrEP cohort study in urban Lilongwe.
- To determine risk factors for HIV in a cohort of AGYW recruited in the prospective cohort study
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A non- randomized study design being implemented in 2 facilities in Lilongwe Urban. The first component is a cross-sectional study of AGYW in which HIV testing counselors will offer HIV tests and assess HIV risk. A sample of AGYW testing HIV-negative and established to be at high risk will be consented to enroll in the PrEP study. In the second component, AGYW who refuse PrEP will be consented to enroll in an HIV incidence cohort study and will be followed every 3 months for 12 months to determine HIV incidence. In the third component, AGYW who consent will be enrolled in a PrEP study. The PrEP study has two phases, which are, (i) a formative qualitative study involving AGYW and PrEP providers to understand factors and barriers to delivering PrEP to AGYW and (ii) a feasibility study of delivering PrEP to HIV negative AGYW. AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW.
| Arm | Type | Receives |
|---|---|---|
| PrEP Cohort | Experimental | Behavioral: PrEP CohortAGYW HIV-negative and established to be at high risk will be consented to enroll in the PrEP study. AGYW will be followed every 3 months for 12 months to determine incidence, assess factors and costs of delivering PrEP to AGYW. |
| HIV Incidence | No intervention | –HIV Incidence Cohort: In the second component, AGYW who refuse PrEP will be consented to enroll in an HIV incidence cohort study and will be followed every 3 months for 12 months to determine HIV incidence. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Eligibility criteria for the cross-sectional study
- Female
- Consent to be counselled and tested for HIV
- Between 18 and 24 years old
- Ongoing HIV risk according to the risk Assessment guide
Key exclusion criteria (11 listed)
- HIV positive
- Under 18 years or older than 24 years at enrollment (including AGYW aged 24 years at enrolment)
- Breastfeeding women
- Already taking oral or injectable PrEP through another study
- Current or past history of renal or liver disease
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 |
|---|---|---|
| PrEP CohortAGYW who are eligible for PrEP will be educated about the risk and benefits. For AGYW (aged 18-24 years) who consent to PrEP, an ART provider (nurse or clinician) certified by the MOH will provide PrEP (package of disoproxil fumarate/emtricitabine (Truvada)) on the same day that the client is determined eligible. Peer navigators will ensure linkage to facilities for follow-up care. The initial follow-up visit will occur one month from PrEP initiation to ensure that the client is tolerating the regimen and to answer any questions, with three-month follow-up visits thereafter. | Behavioural | PrEP Cohort |
Primary outcome
Retention
Time frame: 12 Months
Proportion of participants by risk group and age enrollment who are retained at 3, 6, 9, 12 months after enrollment in each study arm
HIV Incidence
Time frame: 12 Months
Proportion of participants newly diagnosed HIV positive at 3, 6, 9, 12 months after enrollment in each study arm
2 secondary outcomes
Follow-up outcomes
Time frame: 12 months
Uptake
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Sam Phiri, PhD principal investigator
Lighthouse Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Cohort in people with HIV/AIDS, run by Lighthouse Trust at 2 sites in Malawi.
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 20 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. 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 Malawi. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannock Tweya, PhD (+265 1758940 ext. 220, htweya@lighthouse.org.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12 Months). The study lists 2 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 14 Aug 2019.