Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05405582 |
| Other study ID # |
INV-033650 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 26, 2022 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Africa Health Research Institute |
| Contact |
Maryam Shahmanesh, PhD |
| Phone |
07776185572 |
| Email |
m.shahmanesh[@]ucl.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study Hypothesis: Social mobilisation will attract and engage young people into decentralised
sexual reproductive health (SRH) services where HIV prevention is tailored to need.
Decentralised risk informed (differentiated) biosocial HIV prevention will reduce the overall
prevalence of sexually transmissible HIV amongst young people aged 15-30.
Study aims:
1. Measure the impact of social mobilisation into decentralised SRH services that provide
tailored HIV prevention on the prevalence of transmissible HIV.
2. Evaluate the acceptability, practicability, and reach of social mobilisation and
decentralised SRH with tailored HIV prevention to deliver differentiated biosocial HIV
prevention.
Study design: A step-wedge cluster randomised control trial comparing the effect of the
Intervention (social mobilisation by peer navigators into mobile nurse-led SRH clinics) with
Standard of Care (SoC) at Primary Health Care clinics, in reducing the proportion of 15-30
year olds with sexually transmissible HIV and increased uptake of risk-informed
(differentiated) HIV prevention Intervention: Peer navigator social mobilisation intervention
includes safe spaces, structured psychosocial and health needs assessment; Peer-mentorship
with tailored health promotion, psychosocial support and lay-counselling; provision of
condoms, HIV self-tests and pregnancy tests. The mobile SRH clinics provide sexually
transmitted infection (STI) care, contraception, HIV testing and antiretroviral therapy (ART)
if positive and Pre-Exposure Prophylaxis (PrEP) for those eligible (based on national
guidelines) and negative.
SoC at Primary Health care clinics includes, contraception, HIV testing and ART if positive
and PrEP for those eligible and negative.
Population: The eligible population are ~26,000 15-30-year-old residing in 40 administrative
areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal. The 40 clusters will
undergo a stratified randomisation to early versus delayed intervention roll out.
Data collection: Research data will be collected from four sources: i) three random
representative surveys of n= 2000, 15-30-year-olds; ii) programme, process, and clinical
data; iii) qualitative data collected during the process evaluation iv) cost data using
bottom-up ingredient-based costing and top-down costing using the budgets and expenditure
reports.
Study Duration: 36 months.
Description:
This implementation trial aims to measure the effect, of 'social mobilisation into
decentralised SRH services that provide tailored HIV prevention' on the prevalence of
transmissible HIV amongst young people aged 15-30, as well as cost-effectiveness,
practicability and reach.
Trial design: investigators will use a cRCT and realist process evaluation with costings. The
stepped wedge design consists of 40 clusters (administrative areas) randomised to two
intervention steps (early and delayed), 15 months apart. The investigators compare prevalence
of transmissible HIV and uptake of risk-informed HIV prevention in intervention areas with
contemporaneous controls. The investigators will conduct a cost effectiveness analysis and
use a realist process evaluation to interrogate the extent to which the intervention
components deliver according to the theory of change and support demand, uptake and retention
in risk-differentiated biomedical HIV prevention amongst young people. Investigators will use
the process evaluation data to inform any modifications within the intervention arm and to
inform stop/go decisions at the end of step1.
Study setting: The study is taking place in the uMkhanyakude district in rural KZN, which is
mostly rural with over 85% youth unemployment and a high burden of HIV.
Study population and eligibility criteria: About 26,000 young people aged 15-30 residing in
40 administrative areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal are
eligible to receive the intervention and control services. Investigators use the AHRI health
and demographic surveillance as a sampling frame to randomly select three separate
cross-sectional samples of n=3600 (90 per cluster) 15-30-year-olds stratified by gender at
baseline, midpoint (before the second step of scale up) and end-line to measure trial
outcome. Based on previous studies in this setting, investigators anticipate that ~2800 will
be contactable and eligible and that n=2000 (~50 per cluster) men and women aged 15-30, will
be willing and able to provide consent to be included in the study.
Study interventions, eligibility criteria and outcomes are described below
Sample size calculations: Based on current data 8% of the 15-30-year old's have a
transmissible HIV viral load and ~35% are aware of their HIV status and either on PrEP or on
ART and undetectable. With 50 per cluster (n=2000 15-30-year-olds total) in each of the three
survey waves, assuming an ICC within waves of 0.1 for transmissible HIV and 0.4 for
intervention uptake and a decay (autocorrelation) for both outcomes between waves of 0.9, our
two-step stepped wedge trial design provides 90% power to detect an increase from 35% to 47%
in uptake of intervention and 80% power to show a reduction of proportion with transmissible
HIV from 8% to 4% between the intervention and standard of care. The estimates of ICC are
based on the coefficient of variation (k) between clusters estimated in the range 0.7-1.0 for
intervention uptake seen in a trial of peer navigators in the same area. In these
calculations investigators assume that the intervention effect is fully realised within 12
months (gap from baseline to midline survey) and does not decline. Investigators will also
report the intervention effect after 27 months (gap from baseline to end line).
Data collection:
(i) Following informed consent, the participants will complete a 20-30-minute interviewer
administered RedCap survey in IsiZulu. Sensitive questions in this survey are self-filled.
Questions will include awareness of HIV status, awareness and uptake of PrEP/VMMC, ART,
exposure to youth groups, peer navigators, and mobile clinics, sociodemographic, sexual risk
(e.g., number of partners, condom use, and transactional sex), reproductive health (e.g.,
contraception, pregnancy, fatherhood and VMMC); and mental health (PHQ9, alcohol and drug
use). Interviewers will offer point of care HIV testing and collect Dry Blood Spots (DBS) or
pediatric blood collection tubes (<2ml) for HIV ELISA and viral load testing on those that
test positive.
(ii) Investigators will measure linkage to ART/PrEP through identifying eligible young people
who link for PrEP/ prevention counselling or ART initiation within mobile services.
Investigators will use the bar-coded vouchers and other identification within RedCap to
confirm linkage. Within the 11 PHC investigators will use the ClinLink software which is
effective in identifying individuals in the surveillance area and collecting reasons for
attending when they attend PHC. Investigators will look at reasons for attending the 11 PHC
in all 15-30-year-olds through CliniLink as well as ART and PrEP data in tiernet linked to
the HDSS. Investigators will use an algorithm to identify which cluster the individual came
from, including the bar code on the coupon they bring, their name, age, phone number, their
HDSS number, and area of residence.
(iii) Investigators will collect data on uptake and retention in all components of the
intervention in all 26,000 15-30-year-olds in the study area. a) Investigators will collect
the programme data records from the peer navigator tools. This is a RedCap participant
support management tool on the peer navigator tablets. They record the unique ID of the young
people they meet and the GPS co-ordinates, demographic, and contact details of those who
accept health promotion. They then complete a psychosocial and health needs assessment and
record the health promotion, service and/or referral provided. All referrals are made using
barcoded referral slips that are scanned into the tablet. They will finally generate an
action plan including follow-up plans for those who need ongoing support e.g., on PrEP or
ART. b) Youth groups attendance will be recorded (by scanning in barcodes). c) Investigators
will collect clinical data from the RedCap clinical management tool. Investigators will use
the clinical data to record HIV testing, ART uptake if positive, PrEP eligibility screening
and PrEP uptake if negative, and other services received. Investigators will also measure
retention, adherence, and reasons for stopping and/or restarting PrEP. By using this
programme data that links the community outreach with the clinical services investigators
will understand the reach and coverage of the programme. This includes coverage of treatment
and reductions in HIV acquisition as a proportion of all young people in the area and as a
proportion of the young people reached by the programme. Investigators will interrogate any
systematic differences in uptake by gender, age and socio-economic characteristics and
explore what works for whom and how through the process evaluation.
(iv) Qualitative data will include IDIs will be conducted peer navigators (n=10),
nurses/clinical research assistants (n=6) stationed in clinics in the participating
communities, and a purposive sample of young people aged 15-30 years (n=50). The interviews
will be conducted by ARHI trained fieldworkers including a senior social scientist in English
and isiZulu. This will enable the researchers to understand, contextualise and explore some
of the issues around the intervention. To limit disturbances and ensure privacy, the IDI will
be conducted in a private space suitable for the participant, and audio recorded with
interviewees' consents. Researchers will conduct natural group discussions with community
group and intervention delivery staff (n=7; 1 with clinic staff, 2 peer navigators' groups
and 4 community groups (older men, older women and younger men and younger women). The group
discussion will contain 6-8 people and will last approximately 120 minutes.
(v) The study team will work closely with HE2RO to establish costs. Investigators will adapt
the data collection tools that were used in the STAR trial to measure the costs of the peer
navigator intervention to collect bottom-up ingredient-based costs. This will be complemented
with a top-down costing approach using the AHRI study budgets and expenditure reports.
Analysis: An intention-to-treat analysis will be conducted for each primary outcome. A
significance level of 0.05 will be used unless otherwise stated. A detailed statistical
analysis plan will be completed prior to the end of data collection.
To quantify the effect of the intervention on sexually transmissible HIV, the trial
statistician will fit a logistic regression model to estimate the odds ratio (OR) and 95%
confidence interval (CI), adjusting for design factors and survey wave, acknowledging the
clustering of the data through generalized estimating equations. Since randomisation may
result in an imbalance in the distribution of HIV risk factors across the intervention steps,
they will also adjust for pre-specified predictors known to be associated with HIV
transmission risk in this population at cluster and individual level.
To measure the uptake of universal risk informed HIV prevention intervention, the study
statistician will calculate the proportion and 95% CI of participants who consent to
participate in the intervention and are aware of HIV status; on treatment if positive; and
have undergone risk assessment by peer navigators or SRH clinic if HIV negative (and taken up
PrEP if HIV negative and eligible).
To examine the cost of transmissible HIV averted, investigators will measure the costs in
intervention and control arms and compare the two arms in their cost-effectiveness in
achieving endpoints, i.e., the cost per transmissible HIV case averted and the cost per case
linked to risk differentiated biosocial HIV prevention. To establish costs, the investigators
will use both a bottom-up ingredient-based costing approach and a top-down costing approach
using the study budgets and expenditure reports.
Interim analyses: To inform modifications (6months): In the first quarter of the intervention
arm, investigators will look at the uptake of the three different components of the
intervention. Based on the pilot data investigators expect n=13,000 (50%) of all
15-30-year-olds receive at least one structured assessment from peer navigators; 8,000 (30%)
of all 15-30-year-olds are seen in sexual health services; and 1000 (7%) will have engaged
with effective use of PrEP. To be on track to reach these targets, by the first quarter of
intervention role out in all 20 early clusters investigators would expect peers to have
conducted needs assessment on n>=2000; n>=1000 would have been seen in the mobile clinic and
n>= 75 would have started PrEP/ART. If these parameters aren't met in the first quarter the
process data will be used to enhance the intervention. To inform a stop/continue decision: By
the end of step 1 if less 40% (n<5000) of 15-30-year-olds undergo a peer-led needs assessment
and/or less than n< 300 - i.e., less than one third of the 900 we expect to be eligible for
risk informed PrEP - attend the SRH clinic investigators would consider stopping the
intervention.
In-depth Interview Interviews will be based on a topic guide, and it is estimated that they
will take up to an hour. They will be recorded and transcribed verbatim, with the permission
of participants. Data from the IDIs will be analysed using NVIVO software. The software will
be used for categorisation and coding of identified themes from the interview transcripts.
Identified themes (including participants' quotes) and interview transcripts will be reviewed
and compared by the research team for inconsistencies and adequate representation of
participants' comments. A thematic analysis of all interview data will be conducted using
framework approach.
