Clinical trial NCT05481294: Supportive Coaching Intervention in PLWHA
Official title: The Effectivity of Transpersonal Supportive Coaching Intervention on Serotonin Level and Quality of Life in People Living With HIV/AIDS (PLWHA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: Serotonin
Quality of Life
Supportive Coaching
PLWHA
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group was given transpersonal supportive coaching and ARV therapy. Meanwhile, comparison group 1 was given basic support and ARV therapy, and comparison group 2 was only given ARV therapy without any support.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction:

Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.

Objective:

To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.

Method:

This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.

Alternative hypothesis:

1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA

Detailed description: Sampling technique: Purposive sampling

Sample Size :

The estimation of sample size was calculated using the Slovin formula:

n = N / (1 + (N x e²))

n = sample N = population e = margin error (0.05)

n = 100/(1+100 x 0.0025) = 80

The sample will be divided into 3 groups (each group = 26.67 or 27).

Detailed Intervention:

1. Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
2. Control group I: A group was given only basic support for 4 months and taking ARV therapy.
3. Control group II: A group only taking ARV therapy without any support was given.

Statistical analysis:

1. Qualitative analysis using thematic and content analysis with N-Vivo software
2. Quantitative analysis:

   1. Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
   2. Bivariate analysis using Anova or Kruskal Wallis tests.
   3. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
   4. Data will analysis using SPSS version 26

Eligibility criteria: Inclusion Criteria:

* newly diagnosed with HIV maximum 2 months
* Stadium I, II

Exclusion Criteria:

* Stadium III and IV
* Opportunistic infection

Drop Out (DO) criteria:

* Not participating in Supportive Coaching for consecutive 3 times
* Not taking ARV for 1 week

Primary outcomes:
measure: The change in blood serotonin level
timeFrame: The baseline level of serotonin in blood is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention)
measure: The change in Quality of life (QoL) of PLWHA
timeFrame: The baseline score of total and each domain of Quality of Life on PLWHA is measured on the first day before intervention (pre-intervention) and then compared after 4-months of intervention (post-intervention).
Secondary outcomes:
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)
state: South Sulawesi
Study officials:
affiliation: Hasanudddin University
name: Yusuf Tahir, PhD (Cand.)
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanudddin University
name: Firdaus Hamid, PhD
role: STUDY_CHAIR
affiliation: Hasanudddin University
name: Risna Halim, PhD
role: STUDY_CHAIR
affiliation: Hasanudddin University
name: Kusrini S. Kadar, PhD
role: STUDY_CHAIR
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