Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03995953 |
| Other study ID # |
1UG3HD096908-01 |
| Secondary ID |
1UG3HD096908-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
March 11, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
RTI International |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study team will test a multilevel package of interventions to connect adolescent girls
and young women (AGYW) with a source of regular care to provide a sustainable platform for
successful implementation of regular human immunodeficiency virus (HIV) testing and support
for linkage to care, retention in care, and adherence to antiviral treatment. Interventions
will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for
HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW
and their families, and to create community-based youth clubs to foster peer support. A
cluster randomized controlled trial will be implemented with 6 geographic regions randomized
into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD
intervention, and control zones with no intervention. HIV testing will be assessed among the
SHIELD only HIV negative or unknown (HIV-/u) cohort and retention in care along with viral
load suppression will be primarily assessed in the IWC clinics and SHIELD HIV positive (HIV+)
cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback
following the trial. Cost-effectiveness of the interventions and budgetary impacts will be
assessed through using a cost assessment tool.
Description:
The overall goal of this study is to develop and test a multilevel package of interventions
to connect adolescent girls and young women (AGYW) of ages 10-24 in Zambia with a source of
regular care to provide a sustainable platform for successful implementation of regular HIV
testing and support for linkage to care, retention in care, and adherence to antiviral
treatment. To meet the overall goal, the study team will adapt prior tools to create
integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV
Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and
their families, and to create community-based youth clubs to foster peer support. The
researchers will test the hypothesis that the combination of IWC clinics, age-appropriate
SHIELD interventions for AGYW and their families, and peer support will increase HIV testing,
retention in care, and viral load suppression compared to the current standard-of-care
clinical services with or without the SHIELD intervention.
Interventions
The SHIELD intervention is based on social cognitive theory, which posits that positive
behavior change requires knowledge and skills to increase behavioral capability, development
of self-efficacy to increase the belief that one can achieve the desired outcomes, and social
support to provide positive reinforcement and develop positive outcomes expectations. The
researchers will develop a three-session, six-module program for AGYW that increases
knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum,
and a two-session, four-module program for family members to increase social support.
Intervention content for both AGYW and families will be tailored for five distinct groups to
reflect development stage and AGYW's HIV status. Modules will be adapted from existing
evidence-based interventions, such as Stepping Stones and Families Matter! based on community
advisory board (CAB) and youth advisory board (YAB) input and formative research with AGYW,
caregivers, and community leaders. Modules will address HIV prevention and treatment, general
wellness and sexual and reproductive health (SRH), approaches to combat stigma and
discrimination, and skills for better communication, and include new content on health
service availability and access to increase self-efficacy in seeking health care services. In
addition to the education modules, we will establish youth clubs for the five distinct groups
by adapting those created for a prior initiative. Youth clubs will be facilitated by peer
navigators, who will be AGYW aged 16 to 24 years, and trained in participant confidentiality,
AGYW rights, basic counseling skills, overview of SRH and HIV continuum of care, processes of
referral and linkages for health services, recruitment strategies, and study aims.
Formative Research
To inform the adaptation of existing materials and new content for the SHIELD intervention,
the study team will conduct formative research with AGYW, their parents, and community
leaders to explore their perceptions of HIV, stigma, and social support. The study team will
conduct in-depth interviews (IDI) and focus group discussions (FGD) with AGYWs to explore
their knowledge about HIV and the perceived importance of prevention, testing, and
antiretroviral therapy (ART) adherence (as applicable). The study team will examine barriers
and facilitators to HIV care or prevention, with a focus on the types of stigma experienced
and social support. The study team will also explore AGYW's knowledge of availability of
health services and their preferences for service delivery, which will also inform the
discrete choice experiment (DCE) attributes and levels. The researchers will conduct focus
group discussions (FGDs) with parents and other caregivers of HIV-uninfected AGYW, and FGDs
with caregivers of HIV-infected AGYW, to discuss participant's views about their daughters'
access to SRH services and HIV care, the stigma that AGYW and their families experience when
AGYW use these services, and barriers to and facilitators of family support for AGYW's access
to care. Finally, the research team will conduct IDIs with community stakeholders such as
health care providers, church leaders, and teachers to explore their views on how best to
reduce stigma within their communities.
Findings from the formative research will help to identify content that should be adapted or
added to the SHIELD intervention to address locally relevant barriers to HIV prevention,
testing, treatment, and care. The researchers will review the findings and develop draft
training modules and the youth club protocols. The modules will be tested with participants
from each AGYW cohort, families of HIV-uninfected AGYW, and families of HIV-infected AGYW to
fine-tune content and delivery. The data from this pre-testing phase will be used to make
final revisions to the intervention content, manual, and training materials in preparation
for the trial implementation.
IWC Clinic Intervention
IWC clinics will be created within health facilities where AGYWs can receive sexual and
reproductive health services, including HIV testing and treatment, family planning, sexually
transmitted disease screening and treatment, and human papilloma virus (HPV) vaccination. IWC
clinics will be established in existing government health facilities and will follow the
model of the cervical cancer screening clinics. SOPs will be developed to include HIV, HPV
vaccination, and SRH clinical guidelines specific to the AGYW, care pathways mapped out for
common problems or conditions, procedures to maintain patient privacy, quality assurance
checklists, and details on documentation and data capture (pre-programed computer tablets
will be used to enter study data). The researchers will also map out the physical structure
and layout of the room for the IWC to ensure ergonomics in patient care processes and offer
privacy for physical exams. The study team will explore the best options for placement of the
IWC clinic within the health facilities with the use of at least two rooms: one devoted to
the intake process and another for medical examinations. To accommodate AGYW who are
generally not available to attend clinics during work or school hours, the IWC operational
hours will include early morning, late evening, and weekend hours. Given this proposed
schedule, it may be possible to share space with the cervical cancer screening clinic, which
generally has at least two dedicated rooms and operates on a more conventional workday
schedule.
IWC clinic and health center staff will be trained to ensure that staff offer holistic HIV
and SRH services, including family planning, sexually transmitted infection diagnosis and
treatment, and condom promotion, in a nonjudgmental and friendly manner. This training will
include learning the standard operating procedures (SOPs), gaining hands-on experience by
shadowing nurses based at the same facility to understand clinic procedures, and stigma
training that can give staff the skills to create a stigma-free health facility.
Discrete Choice Experiment (DCE)
A DCE along with a supplemental survey will be administered to systematically evaluate
preferences for HIV clinical care services. AGYW will be asked to choose among constructed
scenarios with varying combinations of key attributes relevant to HIV and other clinical care
services (for example, service availability, wait time, operating hours, provider type, and
protection of privacy); choosing not to attend the clinic will also be an option. To permit
use in a low-literacy environment and to ensure an AGYW-tailored approach, the attributes and
levels will be converted into graphics. The DCE selection will generate 200 possible
scenarios based on attributes and levels. To select a fractional set of scenarios (target of
128 profiles), the study team will employ a randomized design process that ensures that
respondents see well-balanced and near-orthogonal fractions of the full-choice design (eight
choice decisions per respondent).
The study team plans to perform sub-analyses by age group and HIV status to assess
differences by developmental stage and have ensured that the sample size of 1,000 HIV-/u
(approximately 330 in three groups) and 800 HIV+ (400 in 2 groups) will be adequate to
perform the planned analysis. In addition to the choice tasks, the study team will administer
a supplemental survey to obtain demographics, socioeconomic status, reproductive history,
access to care, attitudes towards using formal medical care, and stigma associated with HIV
diagnosis. The findings from the DCE will be supplemented with information gained from other
qualitative (interviews and focus groups) and quantitative (patient supplemental survey) data
collection to ensure a comprehensive and context-based interpretation of the results. These
findings will be used to tailor the services, hours of operation, and overall structure of
the IWC clinic-based intervention.
The study team will conduct pilot testing to assess the SOPs in practice, and review the
patient flow and interaction with the IWC staff. The study team will recruit a sample of AGYW
from the clinic catchment area to receive services at one of the IWC clinics. Each AGYW will
be offered HPV vaccination, counseling for HIV testing, and SRH services; the AGYW will also
be encouraged to discuss additional health care needs. Those who choose to receive HPV
vaccination will be given a follow-up appointment so the study team can also monitor the
process of providing the second vaccine dose (second dose will be provided at 6 weeks or 6
months, depending on the 2- or 3-dose schedule; AGYW will be followed to ensure they complete
the required doses, but only the 6-week dosage will be included in the pilot study). The
study team will use time and motion methodology to monitor the AGYW interaction and
activities at the clinic from initial check-in to the end of the visit; the data will be used
to assess patient wait times and disruptions in the patient flow. This information, along
with the feedback from the AGYW (who will undergo a short interview at the end of the first
visit) and the IWC nurse and peer navigator team (interviewed at the completion of all pilot
test visits), will help identify any changes that need to be incorporated to improve the care
processes. The SOPs will be revised by incorporating lessons from the pilot testing, and the
nurses will receive additional training when necessary.
Cohort recruitment and sampling frame
Identify AGYW to establish a sampling frame. In collaboration with the Ministry of Health
(MOH), we will identify six health centers or clinics that provide HIV services and cervical
cancer screening in Lusaka district. The study team will identify AGYW for inclusion in the
catchment areas of these clinics, zones immediately surrounding the clinics. To avoid
potential cross-contamination, the study team will select clinic zones that are not
contiguous. The AGYW recruited using this approach will serve as the cohort for conducting
the DCE and the sampling frame for random selection to participate in the cluster randomized
trial. The sample sizes required for these follow-on assessments were taken into account in
determining the size of the initial HIV-/u and HIV+ cohorts, and the feasibility of
recruiting the targeted number of AGYW is based on prior and ongoing studies conducted by the
grant team. The systematic approach to establishing the sampling frame will provide discrete,
non-duplicated individuals (the participant list will be updated daily); reduce selection
bias by ensuring a more representative sampling for the cluster randomized trial; and also,
if necessary, allow for adjustments in the random selection process so AGYW cohorts are
similar.
To identify the HIV-/u cohort, the study team will map out each neighborhood and households
within the clinic catchment area with the assistance of the local Neighborhood Health
Committees, the community liaisons attached to the clinics, and the outreach staff from the
cervical cancer program. Peer Navigators (PNs) will visit each household, beginning with
residential areas closest to the clinics, to identify eligible AGYW and recruit them to
participate in the study. Participants will be notified of their rights, that questions
regarding HIV status will be discussed, and that their refusal to participate will not affect
their access to health care or other services. All AGYW 18 years of age and older will
provide written informed consent in their preferred language, and parental consent will be
obtained for participants under 18 years of age followed by assent from these minors. The
study team will include one AGYW per household and enroll AGYW on a continual basis until
desired enrollment targets are reached. Participants in the HIV-/u cohort must (a) be female;
(b) be 10 to 20 years of age; and (c) self-report their HIV status as negative or unknown (no
HIV testing within the past 6 months).
The study team has selected the 10 to 20 age group because this is the highest-priority
cohort and because prevention interventions are best targeted to this age group, as high-risk
young women older than 20 years are likely to be HIV positive already. Additional inclusion
criteria include (d) is not pregnant, does not suspect she is pregnant, and does not express
desire to become pregnant over the next 18 months; (e) is willing to sign a release for
medical records (to obtain clinic data on service use); (f) plans to reside in the current
location for the next 18 months; and (g) has not been part of the other planned formative
research activities. The study team is excluding pregnant AGYW because their motivations and
health-seeking behaviors are likely to change during pregnancy, they require specialized
antenatal care, and they are not eligible for the HPV vaccine that will be offered to the IWC
clinic participants. All pregnant AGYW identified during the study will be offered assistance
to obtain care at appropriate antenatal clinics. The study team will recruit 160 to 170
adolescent girls from each clinic catchment area, with equal numbers in 10 to 12, 13 to 15,
and 16 to 20 age ranges, for a total of 1,000 girls.
For the HIV+ cohort, to maintain confidentially, the study team will request that health
providers and community outreach staff at target clinics, along with staff from
community-based testing centers, approach eligible HIV+ AGYW who reside in the clinic
catchment area (identified through patient record review). The use of community outreach
staff will allow targeting AGYW who are HIV+ but not receiving treatment. Those who
voluntarily indicate that they are HIV positive during recruitment of the HIV-/u cohort will
also be given the opportunity to enroll in the HIV+ cohort when eligible. Participants who
are female, 16 to 24 years of age, and diagnosed with HIV within the past 3 years (to target
relatively recently diagnosed AGYW at the time of recruitment) will be eligible for inclusion
in the study. The study team will continue enrollment until the enrollment target is reached.
Those who receive a new HIV+ diagnosis during the 3-month recruitment time frame will also be
included. In Zambia, sexual acts with adolescents younger than 16 years, even if consensual,
are considered criminal. Given the possible negative repercussions that AGYW may experience
should they be reported and our desire to maintain a trusting relationship with the
communities that are served, the study team will not recruit adolescent girls aged 15 years
and younger for the HIV+ cohort. The study team will enroll a total of 800 HIV+ AGYW,
targeting a similar number (130 to 140) from each clinic zone with equal representation among
those 16 to 20 and 21 to 24 years of age. The additional inclusion criteria will also be
applied to the HIV+ cohort.
Data Collection Procedures
The study team will collect data from AGYW, their caregiver (identified by AGYW), clinical
staff, and PNs electronically using computer tablets with pre-loaded software and
instruments. Instruments will be available in English, Bemba, Nyanja, and Tonga as needed. To
facilitate use by younger girls who may not be fully literate, the study team will include a
voice-enabled component, which will allow AGYW to listen and respond to questions. In
addition, AGYW can use the tablet, along with headphones, to self-administer the instrument
to answer sensitive questions related to sexual risk and HIV status. All instruments for data
collection will be created (with adjustments as needed for each AGYW age group) and
pretested, using the same set of AGYW and caregivers selected for pretesting the SHIELD
intervention. The study team will also identify five clinical staff and five PNs who will not
be participating in the study to pretest provider specific data collection instruments. To
ensure the highest level of fidelity and adherence to the protocol, all data collectors will
receive in-depth training and monitoring. Additionally, the study team will be abstracting
required data elements through clinic audit from the six clinic sites included in the study;
the study team have the Zambian Ministry of Health's (MOH's) support to interact with clinic
personnel and conduct record abstraction. The study team will perform pilot data abstraction
to review quality of data at each site and conduct a series of trainings for clinic staff to
address problems identified and implement procedures to ensure high-quality data are
available for the study.
