CClinicalTrials.gg
Status unknownNCT05481294Updated Dec 28, 2022

Supportive Coaching Intervention in PLWHA

An interventional study of Transpersonal Supportive Coaching and Standard Support in HIV, sponsored by Muh. Yusuf Tahir. Status unknown at 1 site in Indonesia. Open to participants aged 17 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Muh. Yusuf Tahir · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
17 Years to 45 Years
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • HIV

Keywords

  • Serotonin
  • Quality of Life
  • Supportive Coaching
  • PLWHA
03

In context

Lead sponsor

This is the only study on the registry with Muh. Yusuf Tahir as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Intervention with Transpersonal Supportive Coaching

    PLWHA is given coaching using standard operating procedures (SOP) for Transpersonal Supportive Coaching to encourage or guide patients in obtaining support. The necessary tool is a representative room for two people with two chairs.

    Other: Transpersonal Supportive Coaching

  • Active comparator
    Intervention with Standard Support

    PLWHA is given standard support provided by peer support foundations

    Other: Standard Support

  • No intervention
    No Support

    PLWHA is not given any kind of support

Interventions

  • OtherTranspersonal Supportive Coaching

    Coaching is given for four months (two times a month) with a 45-minute duration per coaching by a professional coach

  • OtherStandard Support

    Standard support is given for four months using a support system provided by Peer Support Foundation

06

What researchers measure

Primary outcomes

  1. The change in blood serotonin level

    Serotonin (5-hydroxytryptamine, 5-HT) is one of the main neurotransmitters in the human brain that could be affected by psychotherapy (i.e., change the serotonin levels). Total serotonin levels in the blood are measured using the Enzyme-linked Immunoassay (ELISA) method with a standard curve range of 70 ng/L-270 ng/L. The change in serotonin level (i.e., mean score) before and after intervention will be statistically assessed.

    Time frame: 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)

  2. The change in Quality of life (QoL) of PLWHA

    Quality of life is defined as individuals' perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concern which measure using the modified World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) questionnaire in Indonesian version to measure the QoL patients with HIV/AIDS. it is a 31-item instrument consisting of six domains: physical health (4 items), psychological/emotional well-being (5 items), functional/independence (4 items), social (4 items), environmental (8 items) and spiritual satisfaction (4 items). Further, it also contains overall quality of life and general health perception (2 items). Each item's scores range between 1 (very bad) and 5 (very good). A total score and total of each domain at baseline and after the intervention will be statistically assessed. A positive score change indicates good QoL, while a negative indicates worse QoL.

    Time frame: 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).

07

Study locations

1 of 1 sites recruiting
  • Yayasan Kelompok Dukungan Sebaya (Peer Support Group Foundation)
    Makassar, South Sulawesi 90231, Indonesia
    • Rahman Rahim · Contact · +6281342122955
    • Muh.Yusuf Tahir, PhD (Cand.) · Principal investigator
    Recruiting
08

References and documents

Publications

  • Ajisegiri WS, Abubakar AA, Gobir AA, Balogun MS, Sabitu K. Palliative care for people living with HIV/AIDS: Factors influencing healthcare workers' knowledge, attitude and practice in public health facilities, Abuja, Nigeria. PLoS One. 2019 Dec 31;14(12):e0207499. doi: 10.1371/journal.pone.0207499. eCollection 2019. PubMed 31891577 ↗
  • Bradley PJ, Fureder T, Eckel HE. Systemic Therapy, Palliation and Supportive Care of Patients with Hypopharyngeal Cancer. Adv Otorhinolaryngol. 2019;83:148-158. doi: 10.1159/000492359. Epub 2019 Feb 12. PubMed 30943508 ↗
  • Burgess MJ, Zeuli JD, Kasten MJ. Management of HIV/AIDS in older patients-drug/drug interactions and adherence to antiretroviral therapy. HIV AIDS (Auckl). 2015 Oct 27;7:251-64. doi: 10.2147/HIV.S39655. eCollection 2015. PubMed 26604826 ↗
  • Bush SH, Tierney S, Lawlor PG. Clinical Assessment and Management of Delirium in the Palliative Care Setting. Drugs. 2017 Oct;77(15):1623-1643. doi: 10.1007/s40265-017-0804-3. PubMed 28864877 ↗
  • Busolo D, Woodgate R. Palliative care experiences of adult cancer patients from ethnocultural groups: a qualitative systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):99-111. doi: 10.11124/jbisrir-2015-1809. PubMed 26447011 ↗
  • Collins AB, Parashar S, Hogg RS, Fernando S, Worthington C, McDougall P, Turje RB, McNeil R. Integrated HIV care and service engagement among people living with HIV who use drugs in a setting with a community-wide treatment as prevention initiative: a qualitative study in Vancouver, Canada. J Int AIDS Soc. 2017 Mar 3;20(1):21407. doi: 10.7448/IAS.20.1.21407. PubMed 28426185 ↗
  • Gomes B, Calanzani N, Curiale V, McCrone P, Higginson IJ. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD007760. doi: 10.1002/14651858.CD007760.pub2. PubMed 23744578 ↗
  • Harding R, Selman L, Powell RA, Namisango E, Downing J, Merriman A, Ali Z, Gikaara N, Gwyther L, Higginson I. Research into palliative care in sub-Saharan Africa. Lancet Oncol. 2013 Apr;14(4):e183-8. doi: 10.1016/S1470-2045(12)70396-0. PubMed 23561750 ↗
  • Harding R, Simms V, Alexander C, Collins K, Combo E, Memiah P, Patrick G, Sigalla G, Loy G. Can palliative care integrated within HIV outpatient settings improve pain and symptom control in a low-income country? A prospective, longitudinal, controlled intervention evaluation. AIDS Care. 2013;25(7):795-804. doi: 10.1080/09540121.2012.736608. Epub 2012 Oct 31. PubMed 23113572 ↗
  • Head BA, Cantrell M, Pfeifer M. Mark's journey: a study in medicaid palliative care case management. Prof Case Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1097/01.PCAMA.0000343146.81635.38. PubMed 19092600 ↗
  • Hui D. Definition of supportive care: does the semantic matter? Curr Opin Oncol. 2014 Jul;26(4):372-9. doi: 10.1097/CCO.0000000000000086. PubMed 24825016 ↗
  • Krakauer EL, Ngoc NT, Green K, Van Kham L, Khue LN. Vietnam: integrating palliative care into HIV/AIDS and cancer care. J Pain Symptom Manage. 2007 May;33(5):578-83. doi: 10.1016/j.jpainsymman.2007.02.004. PubMed 17482051 ↗
  • Kristanti MS, Setiyarini S, Effendy C. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training. BMC Palliat Care. 2017 Jan 17;16(1):4. doi: 10.1186/s12904-016-0178-4. PubMed 28095837 ↗
  • McNeil R, Dilley LB, Guirguis-Younger M, Hwang SW, Small W. Impact of supervised drug consumption services on access to and engagement with care at a palliative and supportive care facility for people living with HIV/AIDS: a qualitative study. J Int AIDS Soc. 2014 Mar 13;17(1):18855. doi: 10.7448/IAS.17.1.18855. eCollection 2014. PubMed 24629844 ↗
  • Medeiros RCDSC, Medeiros JA, Silva TALD, Andrade RD, Medeiros DC, Araujo JS, Oliveira AMG, Costa MAA, Dantas PMS. Quality of life, socioeconomic and clinical factors, and physical exercise in persons living with HIV/AIDS. Rev Saude Publica. 2017 Jul 20;51:66. doi: 10.1590/S1518-8787.2017051006266. PubMed 28746573 ↗
  • Nkhoma K, Seymour J, Arthur A. An Educational Intervention to Reduce Pain and Improve Pain Management for Malawian People Living With HIV/AIDS and Their Family Carers: A Randomized Controlled Trial. J Pain Symptom Manage. 2015 Jul;50(1):80-90.e4. doi: 10.1016/j.jpainsymman.2015.01.011. Epub 2015 Feb 7. PubMed 25666517 ↗
  • Qiu J, Jiang YF, Li F, Tong QH, Rong H, Cheng R. Effect of combined music and touch intervention on pain response and beta-endorphin and cortisol concentrations in late preterm infants. BMC Pediatr. 2017 Jan 26;17(1):38. doi: 10.1186/s12887-016-0755-y. PubMed 28125980 ↗
  • Souza PN, Miranda EJ, Cruz R, Forte DN. Palliative care for patients with HIV/AIDS admitted to intensive care units. Rev Bras Ter Intensiva. 2016 Sep;28(3):301-309. doi: 10.5935/0103-507X.20160054. PubMed 27737420 ↗
  • Svenningsson I, Petersson EL, Udo C, Westman J, Bjorkelund C, Wallin L. Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression. BMC Fam Pract. 2019 Jul 27;20(1):108. doi: 10.1186/s12875-019-0998-4. PubMed 31351444 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05481294
Lead sponsor
Muh. Yusuf Tahir
Responsible party
Muh. Yusuf Tahir (Lecture, Hasanuddin University) — Sponsor-investigator
First posted
Aug 1, 2022
Start date
Dec 16, 2021
Primary completion
Apr 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Dec 28, 2022

Study contacts

Muh. Yusuf Tahir, PhD (Cand.)
Contact
yusuf_0101@yahoo.com
+628111885522
Firdaus Hamid, PhD
Contact
firdaus.hamid@gmail.com
+6281343788836
Yusuf Tahir, PhD (Cand.)
principal investigator · Hasanudddin University
Firdaus Hamid, PhD
study chair · Hasanudddin University
Risna Halim, PhD
study chair · Hasanudddin University
Kusrini S. Kadar, PhD
study chair · Hasanudddin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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