HIVNCT03751826
Peer Delivery of HIV Self Test to Improve Linkage to HIV Prevention
A study testing Incentivised network delivery of HIV-ST and Peer navigator delivery of HIV-ST in people with HIV, run by University College, London.
Trial summary
Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services. 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
- What is being tested?
- Incentivised network delivery of HIV-ST and Peer navigator delivery of HIV-ST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2019to 31 Dec 2019
- 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
- Females
- Aged 18-24 years
- Not currently on ART
- Provide written informed consent
Who cannot join
- Under 18 years or older than 24 years
- Participants not willing to consent or unable to provide informed consent
- Males
- Currently on ART
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa: A Cluster Randomized Control Trial
Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.
Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa.
Read more
Objectives:
- To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
- To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
- To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
- To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.
Primary Outcomes:
The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.
- Conditions
- HIV
- Being tested
- Incentivised network delivery of HIV-ST, Peer navigator delivery of HIV-ST, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentivised network delivery of HIV-STOther
Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the first intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV themselves and in their peers and friends. They will be counselled to receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
Peer navigator delivery of HIV-STOther
Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the second intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV and then receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
standard of careOther
Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the standard of care arm encourage females aged 18-24 to test for HIV, receive sexual and reproductive health services, contraception and condoms, and link to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
| Study group | Role | What they receive |
|---|---|---|
| Incentivised network delivery HIV-ST | Experimental | Peer-navigators will use respondent-driven sampling to distribute HIV-ST kits through 'seeds'. Each 'seed' (female aged 18-24 years) will receive a session on HIV prevention, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. Seeds will be asked to recruit females aged 18-24 years and given 5 uniquely numbered incentivized recruitment coupons with HIV-ST kits to pass on to their peers. Individual who return the coupons will undergo the same procedure as the seeds above and the individual who handed out the coupon will receive a sum of $1.5 in airtime per friend who returns the coupon. The packs include referral slips with information on how to link to HIV community-based confirmatory testing, HIV treatment and PrEP. Receives: Other: Incentivised network delivery of HIV-ST |
| Peer Navigator distributed HIV-ST | Experimental | Peer navigators will directly distribute HIV-ST kits to females aged 18-24 years over a period of six months. Each person recruited will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV-ST. The packs include referral slips with information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP. Receives: Other: Peer navigator delivery of HIV-ST |
| Standard of care | Active comparator | Peer navigators will encourage females aged 18-24 years to test for HIV at clinics, and link to services/care. Each female aged 18-24 approached by a peer navigator will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. They will then be given a referral slip for HIV testing through the clinic. The referral slips include information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of linkage among women ages 18-24 years to HIV prevention services.
The rate of linkage per month of peer navigator activity to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive.
Measured: within 3 months of receiving the intervention
Secondary outcomes (5)
The number of linkages per 100 clinic referral slips distributed per arm;
The number of linkages to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive per 100 clinic referral slips distributed per arm.
Measured: within 3 months of receiving the intervention.
The change in proportion of all residents (men and women) aged 18-24 years who are aware of HIV-SS and who have used HIV-SS over time
Using routine annually collected data from the surveillance area
Measured: 12 months following intervention end date
Comparison of the difference per study area in the proportion of 18-24 year olds who report knowledge of HIV status and uptake of ART, PrEP and voluntary medical male circumcision (VMMC)
Using routine annually collected data from the surveillance area
Measured: 12 months following intervention end date
Comparison of the pattern of recruitment per arm of study
The proportion of hard to reach adolescent girls and young women (aged 18-24 years) - defined as out of school, recently migrated and those who live in remote areas - linked to care in the three arms of study
Measured: 12 months following intervention end date
Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms
To establish costs, we will use both a bottom-up ingredient-based costing approach and a top-down costing approach using the study budgets and expenditure reports.
Measured: 6 months study implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start14 Jan 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The unit of randomisation will be pairs of peer navigators: 21 pairs of peer navigators will be randomised to 3 arms: two intervention arms, and standard of care (7 pairs per arm).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Health Research Institute, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Maryam Shahmanesh, MRCP PhD, Principal investigator, University College London and Africa Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751826
- Sponsor's protocol ID
- 15990
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to open access data and so we have developed systems to support safe sharing. The data will be managed within the AHRI Data Management Centre, where they are linked to population data. The data is supplied to investigators de-identified.
Publications
Shahmanesh M, Mthiyane TN, Herbsst C, Neuman M, Adeagbo O, Mee P, Chimbindi N, Smit T, Okesola N, Harling G, McGrath N, Sherr L, Seeley J, Subedar H, Johnson C, Hatzold K, Terris-Prestholt F, Cowan FM, Corbett EL. Effect of peer-distributed HIV self-test kits on demand for biomedical HIV prevention in rural KwaZulu-Natal, South Africa: a three-armed cluster-randomised trial comparing social networks versus direct delivery. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004574. doi: 10.1136/bmjgh-2020-004574.
PubMed 34315730Adeagbo OA, Mthiyane N, Herbst C, Mee P, Neuman M, Dreyer J, Chimbindi N, Smit T, Okesola N, Johnson C, Hatzold K, Seeley J, Cowan F, Corbett L, Shahmanesh M. Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol. BMJ Open. 2019 Dec 23;9(12):e033435. doi: 10.1136/bmjopen-2019-033435.
PubMed 31874891
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa: A Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03751826
- Acronym / sponsor ID
- 15990
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Africa Health Research Institute, London School of Hygiene and Tropical Medicine
- Study start
- 14 Jan 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Nov 2018 (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.
Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.
Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa.
Objectives:
- To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
- To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
- To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
- To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.
Primary Outcomes:
The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The unit of randomisation will be pairs of peer navigators: 21 pairs of peer navigators will be randomised to 3 arms: two intervention arms, and standard of care (7 pairs per arm).
| Arm | Type | Receives |
|---|---|---|
| Incentivised network delivery HIV-ST | Experimental | Other: Incentivised network delivery of HIV-STPeer-navigators will use respondent-driven sampling to distribute HIV-ST kits through 'seeds'. Each 'seed' (female aged 18-24 years) will receive a session on HIV prevention, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. Seeds will be asked to recruit females aged 18-24 years and given 5 uniquely numbered incentivized recruitment coupons with HIV-ST kits to pass on to their peers. Individual who return the coupons will undergo the same procedure as the seeds above and the individual who handed out the coupon will receive a sum of $1.5 in airtime per friend who returns the coupon. The packs include referral slips with information on how to link to HIV community-based confirmatory testing, HIV treatment and PrEP. |
| Peer Navigator distributed HIV-ST | Experimental | Other: Peer navigator delivery of HIV-STPeer navigators will directly distribute HIV-ST kits to females aged 18-24 years over a period of six months. Each person recruited will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV-ST. The packs include referral slips with information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP. |
| Standard of care | Active comparator | Other: standard of carePeer navigators will encourage females aged 18-24 years to test for HIV at clinics, and link to services/care. Each female aged 18-24 approached by a peer navigator will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. They will then be given a referral slip for HIV testing through the clinic. The referral slips include information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females
- Aged 18-24 years
- Not currently on ART
- Provide written informed consent
Key exclusion criteria (4 listed)
- Under 18 years or older than 24 years
- Participants not willing to consent or unable to provide informed consent
- Males
- Currently on ART
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 |
|---|---|---|
| Incentivised network delivery of HIV-STPeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the first intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV themselves and in their peers and friends. They will be counselled to receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services. | Other | Incentivised network delivery HIV-ST |
| Peer navigator delivery of HIV-STPeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the second intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV and then receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services. | Other | Peer Navigator distributed HIV-ST |
| standard of carePeer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the standard of care arm encourage females aged 18-24 to test for HIV, receive sexual and reproductive health services, contraception and condoms, and link to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services. | Other | Standard of care |
Primary outcome
The rate of linkage among women ages 18-24 years to HIV prevention services.
Time frame: within 3 months of receiving the intervention
The rate of linkage per month of peer navigator activity to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive.
5 secondary outcomes
The number of linkages per 100 clinic referral slips distributed per arm;
Time frame: within 3 months of receiving the intervention.
The change in proportion of all residents (men and women) aged 18-24 years who are aware of HIV-SS and who have used HIV-SS over time
Time frame: 12 months following intervention end date
Comparison of the difference per study area in the proportion of 18-24 year olds who report knowledge of HIV status and uptake of ART, PrEP and voluntary medical male circumcision (VMMC)
Time frame: 12 months following intervention end date
Comparison of the pattern of recruitment per arm of study
Time frame: 12 months following intervention end date
Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms
Time frame: 6 months study implementation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Derived from this study: PubMed 34315730Shahmanesh M, Mthiyane TN, Herbsst C, Neuman M, Adeagbo O, Mee P, Chimbindi N, Smit T, Okesola N, Harling G, McGrath N, Sherr L, Seeley J, Subedar H, Johnson C, Hatzold K, Terris-Prestholt F, Cowan FM, Corbett EL. Effect of peer-distributed HIV self-test kits on demand for biomedical HIV prevention in rural KwaZulu-Natal, South Africa: a three-armed cluster-randomised trial comparing social networks versus direct delivery. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004574. doi: 10.1136/bmjgh-2020-004574.
- Derived from this study: PubMed 31874891Adeagbo OA, Mthiyane N, Herbst C, Mee P, Neuman M, Dreyer J, Chimbindi N, Smit T, Okesola N, Johnson C, Hatzold K, Seeley J, Cowan F, Corbett L, Shahmanesh M. Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol. BMJ Open. 2019 Dec 23;9(12):e033435. doi: 10.1136/bmjopen-2019-033435.
- Individual participant dataSharing planned: Yes. We are committed to open access data and so we have developed systems to support safe sharing. The data will be managed within the AHRI Data Management Centre, where they are linked to population data. The data is supplied to investigators de-identified.
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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.
Maryam Shahmanesh, MRCP PhD principal investigator
University College London and Africa Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Incentivised network delivery of HIV-ST and Peer navigator delivery of HIV-ST in people with HIV, run by University College, London.
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 4 inclusion and 4 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Carina Herbst (+27 (0)35 550 7500, Carina.Herbst@ahri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of linkage among women ages 18-24 years to HIV prevention services. (time frame: within 3 months of receiving the intervention). 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 NCT03751826, 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 23 Nov 2018.