Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Administrative Supplement
Phase: NA
Conditions: HIV Infections, Mild Cognitive Impairment
Sponsor: University of Alabama at Birmingham

 
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black 
Women Living with HIV Supplement 
 
Principal Investigator:  
Crystal L. Chapman Lambert 
 
Sponsor:  
NCCIH 
 
National Clinical Trial (NCT) Identified Number:  NCT04984681 
 
Version Number:  v1.0 
23 October 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

State of Compliance  
 
The trial will be conducted in accordance with the International Conference on 
Harmonisation Good Clinical Practice (ICH GCP) and the applicable United States (US) 
Code of Federal Regulations (CFR). The Principal Investigator will monitor for 
deviations from or changes to the protocol that are not in accordance with approval from 
the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the local Institutional Review Board (IRB) for review and approval. 
The protocol and the consent form must be approved before any subject is enrolled. 
Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented in the study. All changes to the consent form will be IRB 
approved; a determination will be made regarding whether new consent must be 
obtained from subjects who provided consent using a previously approved consent 
form. 
 
Study Synopsis 
 
Title: 
Feasibility of the Mindfulness-Based Stress Reduction (MBSR) 
Intervention for Black Women Living with HIV Supplement 
Study Description: 
Black women living with HIV are at higher risk for experiencing 
stressful life events which can lead to deleterious health 
outcomes. MBSR offers a complementary and integrative 
approach for reducing stress as a mechanism for improving 
health outcomes. This is a randomized control pilot test aims to 
explore if MBSR is practical in the target population.  
Objectives: 
 
To conduct a 2-armed pilot test of the behavioral intervention 
compared to the standard of care to assess the feasibility and 
acceptability of an adapted mindfulness-based intervention for 
Black women living with HIV with mild cognitive impairment. 
Endpoints: 
Feasibility of the intervention 
Study Population: 
Black women living with HIV with mild cognitive impairment 
Phase: 
Stage I: Feasibility and pilot testing 
Description of 
Study Intervention: 
The intervention consists of the following: (1) a series of eight 
weekly session of 2.5 to 3 hours; (2) a silent retreat during the 
sixth week; (3) daily home assignments including formal and 
informal mindfulness practices; and (4) didactic presentations 
on stress and the consequences of stress. 
Study Duration: 
The estimated study duration of the randomized pilot study 
(e.g., from IRB approval to screening to finishing the study) is 
approximately 18 months. 
Participant 
Duration: 
The estimated participant duration (e.g., from pre-survey to 
post-survey) is approximately 3 months. 

Schedule of Activities 
 
Procedures 
Pre-
screening 
(consent)
Visit 1 
(Week 1) 
Visit 2 
(week 2 ± 7 
days)
Visit 3 
(week 3 ± 7 
days)
Visit 4 
(week 4 ± 7 
days)
Visit 5 
(week 5 ± 7 
days)
Visit 6 
(week 6 ± 7 
days)
Visit 7 
(week 7 ± 7 
days)
Visit 8 
(week 8 ± 7 
days)
Visit 9 
(week 8 ± 7 
days)
Visit 10 
(week 9 ± 7 
days) 
Visit 11 
(week 10 ± 
7 days) 
Visit 12 
(week 11 ± 
7 days) 
Eligibility via EMR review  
X 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographics survey 
 
X 
 
 
 
 
 
 
 
 
 
 
 
MBSR components 
 
 
 
 
 
 
 
 
 
 
 
 
 
Orientation  
 
 
X 
 
 
 
 
 
 
 
 
 
 
8-weekly sessions 
 
 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Retreat 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Post-intervention interview and survey 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 

Purpose 
 
The primary purpose is to assess the feasibility of an adapted mindfulness-based 
intervention for Black women living with HIV with mild cognitive impairment. Please note 
that we are not seeking to determine the efficacy of the study. Slight deviations from the 
protocol are allowed with the goal of assessing efficacy in a future study.  
 
Background 
 
With access to effective antiretroviral therapy (ART), HIV is a manageable chronic 
disease. The life expectancy of people living with HIV (PLWH) is similar to that of the 
general population with optimal adherence to medical visits and ART1. As a result, PLWH 
rarely experience HIV-associated dementia; yet, cognitive impairment is common among 
PLWH due to both HIV and aging2. PLWH are seven times more likely to have mild 
cognitive impairment (MCI) than people without HIV3, which increases their risk of 
Alzheimer's disease and related dementias (ADRDs). Such cognitive impairment 
significantly impacts important daily functioning abilities, including medication adherence3, 
4.  
Among PLWH, gender and racial disparities in cognitive impairment have been noted. 
Women living with HIV (WLWH) have an increased risk of poor cognitive function relative 
to their male counterparts living with HIV and women without HIV5-10. Further, African 
American (AA) WLWH are more likely to display cognitive impairment than their White 
female counterparts9. The observed differences in cognitive function are significant as the 
HIV epidemic disproportionately burdens AA WLWH in the US. AA WLWH account for 
60% of WLWH and have mortality rates 17 times higher than rates observed for White 
WLWH11. Increased mortality among AA WLWH is associated with suboptimal ART 
adherence and failure to achieve and sustain viral suppression (VS), which is notably 
lower in AA WLWH compared to White WLWH12. Given the disparities noted in both poorer 
treatment outcomes and poorer cognitive functioning among AA WLWH, there is a critical 
need to develop therapeutic strategies that mitigate the cognitive impairment among AA 
WLWH. 
Literature in the general population suggests that demographic, psychosocial, and 
intrapersonal factors, including socioeconomic status, age, depression, stress, and PTSD, 
are significantly associated with increased risk of developing cognitive impairment13-20. 
Within PLWH, HIV biomarkers (e.g., low CD4 count, higher viral load) are also associated 
with poor cognitive function among WLWH8, 10. Given that AA WLWH are at increased risk 
of both traditional cognitive impairment risk factors (e.g., stress, depression) and worse 
HIV severity, culturally-relevant, and gender-specific interventions to mitigate cognitive 
dysfunction are warranted.  
There are no known cures for ADRD. Mindfulness-based stress reduction 
(MBSR) is a promising non-pharmacology strategy that may improve or stabilize 
cognition21-23 in the general population and among specific clinical populations (e.g., 
female breast cancer survivors)24; yet, studies among PLWH, including WLWH are 
lacking25, 26.  
 
 
 

Study Aim 
 
Conduct a two-arm randomized pilot test of the adapted intervention compared to usual 
care among 30 Black WLWH (15/arm) to assess the feasibility of an adapted intervention. 
 
Study Design 
 
The study presented in this protocol is a pilot randomized controlled trial with two parallel 
groups and a primary endpoint of intervention feasibility. Participants will be randomized 
(1:1) allocation to either the control arm (usual care) or the experimental arm (MBSR).  
 
Study Setting 
 
Participants will be recruited from an academic ambulatory care clinic in the Southern US. 
The clinic provides comprehensive care to people living with HIV.  
 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
1) Cisgender females  
2) HIV seropositive  
3) 18 years of age or older 
4) Able to speak English 
5) An active patient at the study site 
6) Have mild cognitive impairment 
 
Exclusion Criteria 
1) Unable to speak English  
2) Appearing temporarily impaired (e.g., intoxicated), or 
3) Unwilling to or legally able to provide informed consent. 
 
Recruitment Procedures 
 
We will use multiple methods for recruitment. Our primary method of recruitment is via a 
data query. Research staff will also run a data query of the outpatient HIV clinic EMR to 
produce a list of patients who meet the eligibility criteria.  The list will be provided in the 
form of an Excel Spreadsheet that includes the patient’s name, MRN, next scheduled 
clinic appointment, viral load and missed visit data for the previous 12 months, and phone 
number.  Study staff will create a list of patients to approach at their clinic appointment to 
discuss the study.  If the upcoming clinic appointments are not scheduled to occur soon, 
study staff will call potential participants using the recruitment script and ask if they are 
interested in participating. Once we have exhausted the list, if needed, we can then recruit 
using flyers or a data query.  Once a potential participant calls about the study, a member 
of the study team will use the screening script to ask questions as well as review the 
potential participant’s HIV clinical data (CD4 and HIV viral load). We requested a partial 
waiver of authorization for recruitment and screening. 

 
Once eligible has been determined and verbal informed consent has been given. We will 
randomize women to either the treatment condition (MBSR; n=15) or usual care condition 
(usual care; n=15). Participants will receive a phone call and or text message reminder 
1-2 days prior to the session. If participants are not present at the time of the session, 
then a member of the research team will contact the participant via phone or text message.  
 
Study Intervention  
 
We recruit and randomize women to either the treatment condition (MBSR; n=15) or usual 
care condition (usual care; n=15). Participants will be randomized to the intervention or 
control group using an excel-based randomization algorithm that matched conditions 
based on age and missed scheduled medical visits. The control group will continue to 
receive usual care per the HIV treatment guidelines in a team environment. The academic 
health center’s HIV primary care clinic has implemented a team-based model of care in 
which physicians, nurse practitioners, nurses, social workers, counselors, and 
nutritionists collaborate to provide high-quality, affordable care to each patient. We 
decided to use usual care as the control group because previous research has 
demonstrated that using a matched time and attention group may have non-study effects 
outside of the intervention that influence outcomes 27, 28. In addition, the primary goal of 
this study is to assess the feasibility of MBSR for Black WLWH who are currently receiving 
evidence-based care. Thus, MBSR will be an addition to usual care, which makes usual 
care a valid control condition 29. MBSR sessions received by the treatment group will 
include an orientation, about 8-weekly sessions, and a retreat. The orientation session 
will be approximately 3 hours and include an overview of MBSR and mindfulness practice 
and discussion. Sessions 1-8 will be approximately 2.5 hours and include a brief opening 
meditation practice, additional meditation practices (e.g., body scan, focused awareness, 
yoga, etc.), group discussion, and recommendations for home practice. The retreat will 
be approximately 5 hours on a mutually agreed day between regularly scheduled 
sessions, and the activities for the retreat include group mindful eating, reviewing 
previously learned meditation practices, learning new practices, and group discussion. All 
participants will complete a pre-and post-intervention survey for feasibility purposes, not 
to determine efficacy or pre/post-intervention changes. This practice is not allowed by 
NCCIH. The intervention delivery format was changed from face-to-face to 
videoconferencing because of University COVID policies, and IRB approval was 
obtained.  
 
Potential Risks Versus Benefits 
 
There are minimal risks associated with this study. We will discuss stressful life events 
and other potentially sensitive subjects such as personal history of depression and HIV. 
This may cause emotional or psychological distress, and we want you to tell us if you feel 
distressed. We can always request a break or stop the study visit, and we can get 
additional help for you from a clinic social worker, psychologist, or counselor. In addition, 
we also ask you to perform mental tests that you may find difficult, uncomfortable, or 
embarrassing; however, these tests are designed to measure your peak mental abilities. 

For many individuals, as they want to do their best, it is normal to feel anxious or worried 
about not doing well on such tests. We just ask that you do your best, but please keep in 
mind that no one scores perfectly on these tests. 
 
During the group discussions, we will ask participants to refrain from using names and 
not discuss other participants with individuals outside the group. There is a risk that you 
may accidentally use your name during the session. A member of the research team will 
remove participants’ names from the transcripts.  
 
There are no guaranteed benefits directly to the participant. However, participants may 
notice improvements in awareness and increased knowledge of mindfulness.  
 
Participant Discontinuation/Withdrawal from the Study 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following 
reasons: 
 
• Significant study intervention non-compliance  
• If any serious adverse event (AE) or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of 
the participant. 
 
Participants who complete the informed consent process and are randomized but do not 
receive the study intervention may be replaced.  Participants who complete the informed 
consent process, and are randomized and receive the study intervention, and 
subsequently withdraw, or are withdrawn or discontinued from the study, will not be 
replaced. 
 
Lost to Follow-up 
 
A participant will be considered lost to follow-up if she fails to return for two scheduled 
visits and cannot be contacted by the study staff.  
 
The following actions must be taken if a participant fails to be available for a required 
study visit: 
• A study staff member will attempt to contact the participant to determine the 
reason for the missed visit, counsel the participant on the importance of attending 
scheduled study sessions, and ascertain if the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or a study staff 
member will make every effort to regain contact with the participant (where 
possible, up to 3 telephone calls).  

• Should the participant continue to be unreachable, she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
Adverse Events 
 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 
(a)). 
 
An adverse event (AE) is considered “serious” if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: 
 
• Death 
• A life-threatening adverse event (of note, the term “life-threatening” refers to an 
event in which the subject was at risk of death at the time of the event, rather than 
to an event which hypothetically might have caused death if it were more severe) 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
 
There is no expectation of any adverse events or outcomes related to participation in this 
study. Participating in behavioral interventions such as mindfulness interventions is 
considered minimal risk.  All participants will be given access to contact a study team 
member and advised to report any adverse events to the study team immediately. The 
study staff members will not specifically ask about adverse events during the study visit 
or reminder calls. Study staff members will ask participants to share voluntarily the reason 
for any missed research visits. 
 
The PI or a member of the study team will record death with start dates occurring any 
time after informed consent is obtained until 30 days after the last day of study 
participation. All serious adverse events must be reported to the IRB according to 
regulatory requirements. 
 
Statistical Analysis Plan  
 
We hypothesize that the mindfulness intervention will be feasible among Black women 
with HIV with mild cognitive impairment.  
 
The primary endpoint for this study is feasibility, which will be measured by the feasibility 
of the intervention measure30, which consists of four items measured on a 5-point scale 
ranging from “Completely disagree” (1) to “Completely agree” (5).  
 
Our sample size considerations are based on information obtained by previous studies in 
terms of sample size for pilot projects 31, 32, successful feasibility studies of medication 
adherence in HIV patients 33, 34, and successful feasibility studies of MBSR in populations 
with chronic disease35, 36. Given the limited sample size and primary objective of this 

application, which is to assess the feasibility and acceptability of the adapted intervention 
in the target population, this study is not powered sufficiently to formally detect significant 
group differences. We will not use our data to estimate an effect size for a future larger-
scale study due to the high degree of uncertainty of estimates from small samples and 
where multiple measures are examined 31. However, we will use descriptive statistics to 
describe sample characteristics. Bivariate analysis will be conducted between groups 
using measures of effect size (e.g., Cohen’s d, d-equivalent, odds ratios, etc.) and 95% 
confidence intervals around these measures.  
 
Regulatory, Ethical, and Study Oversight Considerations 
 
Consent forms describing in detail the study intervention, study procedures, and risks are 
given to the subject, and verbal documentation of informed consent is required prior to 
conducting study randomization procedures. A separate screening consent form will not 
be used. 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study and continues throughout the individual’s study participation. 
Consent forms will be Institutional Review Board (IRB)-approved, and the subject will be 
asked to read and review the document. The investigator or a member of the research 
team will explain the research study to the subject and answer any questions that may 
arise. A verbal explanation will be provided in terms suited to the subject’s comprehension 
of the purposes, procedures, and potential risks of the study and of their rights as research 
subjects.  Subjects will have the opportunity to carefully review the written consent form 
and ask questions prior to providing verbal consent. The subjects should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to 
agreeing to participate. The subject will provide verbal informed consent, which will be 
witnessed and documented by a member of the study team prior to any procedures being 
done specifically for the study. Subjects must be informed that participation is voluntary 
and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the subjects for their records. The rights and 
welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
Subject confidentiality and privacy are strictly held in trust by the participating 
investigators and their staff. Therefore, the study protocol, documentation, data, and all 
other information generated will be held in strict confidence. No information concerning 
the study, or the data will be released to any unauthorized third party without prior written 
approval of the PI.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the IRB may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, 
or hospital) and pharmacy records for the subjects in this study. The clinical study site will 
permit access to such records. 

 
The study subject’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept 
in a secure location for as long a period as dictated by the reviewing IRB and/or 
Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific 
reporting, will be stored at the UAB School of Nursing. This will not include the subject’s 
contact or identifying information. Rather, individual subjects and their research data will 
be identified by a unique study identification number. The study data entry and study 
management systems used by research staff will be secured and password protected. 
 
Study documents should be retained for a minimum of 3 years after the completion of the 
study. These documents should be retained for a longer period, however, if required by 
local regulations. 
 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical.  Therefore, any actual conflict of interest of persons 
who have a role in the design, conduct, analysis, publication, or any aspect of this trial 
will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the design and conduct of this trial.   
 
 

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