Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05482217 |
| Other study ID # |
UBotswana |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 26, 2021 |
| Est. completion date |
May 3, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Botswana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim: To explore the effectiveness of psychoeducation and problem-solving (Life-steps) on
depression and adherence in HIV-infected adolescents.
Methods: Forty-two adolescents were randomized into 21 controls and 21 intervention groups.
The intervention group was exposed to 5-week sessions of life steps applied by a lay
counselor. The PHQ-9 and visual analog scale (VAS) were used to measure the outcomes:
depression and adherence. They were applied at baseline, 5-weeks, and 24 weeks
post-intervention.
Description:
General objectives
To explore the effect of psychoeducation and problem solving (LIFE STEPS) technique on
medication adherence and depression among mentally ill ALWHIV in Botswana.
Specific Objectives
1. To compare the sociodemographic and clinical variables of the ALWHIV: intervention and
control group
2. To explore the effect of psychoeducation and problem solving (LIFE STEPS) on medication
adherence and depression among ALWHIV.
Methodology Study Design: Randomised controlled trial to assess the psychological
intervention program.
Study sites: The facilities in Gaborone are Baylor children's clinical center of excellence
(BCOE), and Princess Marina HIV clinics (PMH).
Subject Population(s) Phase 1: HIV infected adolescents aged, 12 - 19 years.
Subject Recruitment/Sampling Methods:
Using techniques described to determine the sample size for continuous outcome in a
randomized controlled trial, a minimum sample size of 25 in each group was calculated to be
sufficient to identify a treatment effect of one standard deviation difference in adherence
scores based on 5% level of significance and 90% power. A significant treatment effect is
expected due to the enormous treatment gap in Africa, such that slight increases by simple
interventions will produce huge outcomes. An initial adherence cut-off of less than 95% in
VAS visual analog, meeting the criteria for depression on MINI-KID, and a score of 9 and
above on PHQ-9 were used for inclusion in the study. Twenty-five participants each were
recruited in anticipation of a 25% attrition rate for the intervention and the control
groups.
A two-stage random sampling method was adopted to select the participants from the sub-sample
of the phase one study. The first stage was to select from those who meet the criteria for
the second phase, and the second phase was to allocate the selected sample into two groups
randomly. Everyone eligible to participate in the second phase, that is, those who are below
the cut-off as earlier alluded to (after the first analysis with SPSS), was given a separate
identification number that was linked to their contacts in such a way that their identities
(names) were concealed. The sheet that has the identification numbers and contact of the
participants was kept separately (locked in a safe cabinet) by the principal investigators
(PI). It was only used for follow-up purposes and was destroyed immediately after the study.
The identification numbers of all who are eligible for phase II were entered into the SPSS
software, which was used to randomly generate some identification numbers, i.e., 50
participants who were contacted. This process of generating numbers was repeated until 50
participants who are willing to participate were enrolled. These people (with their
caregivers) were invited and asked to give their consent/assent after explaining the
procedure to them. They were informed about the possibility of being allocated into either an
intervention group or control. Those who attended the intervention session and the other
group were informed on what to do through their preferred medium of communication. However,
the outcome and the detail of the intervention were not discussed with any of the group so as
not to introduce a bias. Subsequently, a simple ballot system was used, where folded papers
marked with the two choices (intervention = 'I' and control 'C') were presented to all the
participants. They were asked to pick one of the folded papers, and the letters they pick
indicated which group they belonged to, i.e., 'I' or 'C.' They were informed depending on the
letter they pick without telling them the meaning of the letters and the next step to take.
Data Collection Methods Permission was first obtained from the relevant authorities, namely
the Ministry of Health and all the health facilities where the recruitment will be done.
Written informed consent was obtained from those who have reached the age of consent (18 and
19 years), whereas parental consent and assent were obtained from adolescents below the age
of consent (less than 18 years) before commencing the study. This was done by explaining the
intention, the benefit, and the risk in an elementary language to all the eligible
participants within this age group. Those who refused to agree were exempted from the study
regardless of the decisions of their parents or guardians.
A research assistant (RA) was employed and adequately trained in the research instruments and
on how to approach the parents and the participants on the clinic days. Specialized training
was given on how to obtain information from very young adolescents on sensitive issues. The
RA was trained on how to establish rapport, be patient, instill confidence, and be sensitive
to their emotional needs. She was trained on how to engage them and when to disengage and or
break the interview. A light refreshment was offered within a reasonable limit and without
causing an unnecessary inducement.
Fifty adolescents screening positive for depression and poor medication adherence were
randomly selected from the first sample (phase I of the study), and randomly allocated into
two groups of 25 intervention, and control as alluded to previously. Suitable participants
selected from the centers were informed of the objective of the second phase. Their parents
were also informed of the plan to psycho-educate them for five weeks. Another consent and or
assent were obtained from them before they can be eligible to partake in the second phase.
The participants were made to sit in a small group of five per table, and they were grouped
according to their age group into early adolescent (12-14, mid-adolescent (15-17), and late
adolescent (18 and above). This enabled the identification of, and attention to the
age-specific needs. The meetings were in a comfortable and familiar room that was organized
at BCOE. Items such as markers, white paper, paper tape, stickers, a board, a projector, and
a computer were supplied. A manualized psychoeducation and problem solving (LIFE STEPS)
program on treatment adherence was delivered by a trained lay counselor and supervised by the
PI. The program consisted of five structured sessions offered weekly, each lasting 50-60
minutes. The session is basically on identifying problems (such as psychological problems,
stigma, and, other related issues), and providing guidance on how to provide adaptive
solutions which are age-specific to them.
The sessions were delivered as interactive lectures and small group discussions. They involve
interactive discussion, role play, and brief lectures. The plenary sessions which took less
than 15 minutes of the sessions were divided majorly into 2 or 3 parts according to the age
group, even though they took place concurrently. A few minutes were spent on short relaxation
and light exercises. Homework was given after every session. All sessions started with a
review of the subject learned in the previous week to allow participants to share how they
practiced their skills with the other members of the group. All sessions also started with a
brief and simple exercise, such as stretching, clapping, and dancing. At the end of each
session, there was also a recapitulation of what had been learned, and new assignments are
given to enable participants to practice the new skills. There was a recap of overall
sessions based on observations and feedback, where the participants were asked to rate each
session on its usefulness and ease of understanding. Transport fares and refreshments were
available for the participants.
This rating was on a scale of 1- 10 (1 = not useful or easy to understand, and 10 = very
useful or easy to understand also take feedback). Two sessions were randomly selected for
audio-recording and were assessed by the supervisor to confirm adherence to the manual. The
adherence questionnaires and PHQ-9 were applied at pre-, immediate post-intervention, and 24
weeks. Any change in the level of adherence and depression was measured across groups after
exposing the experimental group to five weeks of brief psychological intervention.
Measures Socio-Demographic and Clinical Characteristics Datasheet This subsection consisted
of relevant questions on the socio-demographic characteristics of the respondents such as
age, religion; ethnicity; position in the family; parent's marital status, educational level,
and gender. This also included questions on type and level of social support, clinical
variables such as mode of HIV transmission, age at first diagnosis (HIV), previous and
current CD4 count, and viral load. Other relevant clinical variables such as frequency of
clinic attendance and level of adherence were retrieved from their records with their
permission and those of their parents. This section of the questionnaire was designed by the
researcher based on a review of previous studies.
MINI-KID MINI-KID is a brief structured clinical diagnostic interview designed to assess the
existence of 24 ICD-10 and DSM-IV mental disorders comprehensively and concisely. This
interviewer-administered instrument is suitable for adolescents and has been used in various
populations, including HIV adolescents in sub-Saharan African settings.
All the instruments were translated into Setswana (the predominant language in Botswana)
using the procedure of iterative back-translation by a panel of bilingual experts.
Depression: Patient Health Questionnaire (PHQ-9) is a depression module, which is
provisionally used to diagnose depression and grade the severity of symptoms in general
medical and mental health settings. It has nine items based on the Diagnostic and Statistical
Manual of Mental Disorders, fourth edition (DSM-IV) criteria, and the scores range from "0"
(not at all) to "3" (nearly every day). ThePHQ-9 has been validated for use in Botswana. The
cutoff of 9 or more is consistent with a diagnosis of a major depressive episode in Botswana
and will be used for inclusion in this study.
Data Analysis The study outcomes were depression (measures using PHQ-9) and treatment
adherence (VAS). Between groups, comparisons were made based on the intention-to-treat
sample. The study collected data for baseline, 5-week, and 24-weeks follow-up. Data from the
24-weeks follow-up was collected from only the intervention group. Wilcoxon rank-sum test was
used to assess the differences between the intervention and control groups at various time
points when the outcome is in a continuous format. Changes in depression and adherence score
over time within assigned groups were assessed using Wilcoxon signed-rank test (if two-time
points) and Friedman ANOVA (more than two-time points). The effect size was calculated based
on Wilcoxon signed rank where r=|z/√N|. The magnitude was based on Cohen's classification of
effect sizes which is 0.1 (small effect), 0.3 (moderate effect), and 0.5 and above (large
effect). The relationship between the two outcomes (PHQ-9 and VAS) scores was assessed using
Spearman correlation.
