HIV Clinical Trial - Supportive Coaching Intervention in PLWHA

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05481294
Study type	Interventional
Source	Hasanuddin University
Contact	Muh. Yusuf Tahir, PhD (Cand.)
Phone	+628111885522
Email	yusuf_0101@yahoo.com
Status	Recruiting
Phase	N/A
Start date	December 16, 2021
Completion date	June 30, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.