Effectiveness of Self-stigma Reduction Intervention Program in Improving Psychological Status and Anti-tuberculosis Treatment Adherence Among Tuberculosis Patients of Hargeisa Tuberculosis Hospital - Somalia: A Randomized Controlled Trial

Last registered on October 01, 2023

Pre-Trial

General Information

Title

RCT ID

AEARCTR-0012166

Initial registration date

September 22, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published

October 01, 2023, 9:08 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country

Malaysia

Region

Sabah

Primary Investigator

Name

Mohamed Hashi Faraade

Affiliation

University Malaysia Sabah (UMS)

Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status

Completed

Start date

2020-02-01

End date

2020-12-31

Keywords

Behavior, Health

Additional Keywords

Intervention, Tuberculosis, TB Stigma, Hargeisa-TB-Hospital, Somalia.

JEL code(s)

N/A

Secondary IDs

N/A

Prior work

This trial does not extend or rely on any prior RCTs.

Abstract

ABSTRACT
Mycobacterium tuberculosis is a type of bacteria that typically affects the lungs. InSomalia, TB is a leading cause of death and illness burden. Stigma is a major
impediment to the global eradication of tuberculosis (TB). And one of the manyfactors hampering tuberculosis (TB) control, and treatment adherence. Self-stigmaremains an undesirable psychological behavior that has an impact on patients’ lives. So far self-stigma is often continued beyond the period of infection, treatment, andhindering complete recovery. At present, there is no self-stigma interventionreduction program in Somalia that is directed TB patients to improve medicationadherence. A Literature search on the effect of self-stigma intervention amongTBpatients is not available. However, the effect of Psychological counselingandeducational interventions on TB treatment adherence based on HBMrevealedastatistically significant difference between the intervention and control at theendpoint of the intervention. Objective: To develop, implement and evaluatetheeffectiveness of self-stigma intervention reduction to improve the psychological
status, basic TB knowledge, and TB treatment adherence based on HBMamongTBpatients in Hargeisa TB Hospital Somalia. Methods: A randomized controlledtrial
was conducted to determine the effectiveness of a recently developed self-stigmaintervention program on improving psychological status, basic TB knowledge, TBtreatment adherence, and reduced TB stigma. The intervention group receivedHBM-based stigma intervention program including stigma related to TB, basicTBknowledge, adherence to TB treatment, clarification of myths and misconceptionsas videos, ppt lectures, And the control group received standard TB treatment. Results: The study results showed significant change differences in the stigmaTBcommunity and stigma TB patients’ reduction, improved knowledge, and adherenceto treatment between the intervention and control group at baseline, two, andsixmonths follow-up. Basic TB knowledge between the intervention and control group[mean score = 3.467 (0.148) vs. 2 months, [ms = 13.980(0.148) vs 2.54 (0.149), and 6 months, ms = 13.980(0.148) vs 2.54 (0.149), F(1,305) = 1811.5, p<0.001. In adherence to TB medication in the intervention group as compared tothecontrol group, [mean score = 2.65 (0.98) vs. 2 months, [ms = 9.91(0.31) vs 2.54(0.77), and six months, ms = 9.92(0.33) vs 2.54 (0.77), F(1,305) =5052, p<0.001]. Community TB stigma and patients TB [Meanscore = 29.191(0.229) vs. 29.893(0.231)]. 2 months, [ms = 12.132(0.091) vs 29.893(0.092), and6, ms=12.132(0.084) vs 30.000, (0.085), F(1,305) = 7905, p<0.001]. as well as:
[Meanscore = 25.145(0.199), vs 25.940(0.201),)]. 2 monhs, [ms =13.105(0.109)vs 25.940(0.109) and 6, ms=11.230(0.350) vs 25.567(0.352), F(1, 305)=1930.7, p<0.001] respectively). Conclusion: The self-stigma reduction interventionprogram based on HBM, was effective in improving, knowledge, adherencetotreatment, and reduced stigma, among TB patients.
Keywords: Intervention, Tuberculosis, TB Stigma, Hargeisa-TB-Hospital, Somalia.

External Link(s)

Registration Citation

Citation

Faraade, Mohamed Hashi. 2023. "Effectiveness of Self-stigma Reduction Intervention Program in Improving Psychological Status and Anti-tuberculosis Treatment Adherence Among Tuberculosis Patients of Hargeisa Tuberculosis Hospital - Somalia: A Randomized Controlled Trial." AEA RCT Registry. October 01. https://doi.org/10.1257/rct.12166-1.0

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Experimental Details

Interventions

Intervention(s)

The Intervention
The self-stigma intervention module on stigma-related TB intervention, regarding the reduction of stigma and stigma-related to tuberculosis among TB patients was developed through a process of consultations with a group of experts in preventive medicine and behavior modification. The module was developed based on the Health Belief Model (HBM) model which has six components as determinants of health behavior change including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. The HBM components in the model were aimed at disseminating information on reducing the stigma associated with tuberculosis. A structured intervention program, aimed at introducing a systematic way of reducing stigma related to tuberculosis. the implementing of intervention was started as a step by step from an outpatients visiting of Hargeisa TB hospital Somalia were screened then PTB Smear positive (+) was set a side, an eligible Patients were recruited after that randomized and baseline data collection were collected then promptly intervention module implemented. An agenda was developed for the training face-to-face method, using PowerPoint presentations video lecture programs, and small group discussions with clear messages on Stigma related to TB, treatment adherence, and myths and misconceptions about tuberculosis. Also included essential program of teaching exercise delivered in 1 day for 7 hours. One day for the intervention group. Five facilitators from the TB Control Program department participated. Before the expert of Public Health, the investigator delivered the intervention facilitator training conducted 2 weeks before the intervention. Each group was divided into 5, a maximum of 30 participants per group. The intervention was given at the first encounter and a booster at 2 months to reinforce learning. The questionnaire for data collection was administered at baseline, 2 months, and 6 months later. The intervention was conducted in the hospital premises and participants provided meals and transport allowance. The intervention was provided to the intervention group until the end of the program so that their continued benefit. In details he intervention arm: (DOT) directly observed treatment. self-stigma reduction intervention module included: Basic Knowledge about TB as ppt & video lectures. PowerPoint presentation about the stigma related to TB. PPT and video about TB treatment adherence. PowerPoint and video lectures about myths and misconceptions regarding TB. Health education about the TB related Self-stigma and Stigma as a general counselling. TB medication (DOT)lectures. Adherence to TB treatment counselling. SMS remainders. And the control arm received standard practice of TB treatment (DOT) directly observed treatment.

Intervention Start Date

2020-02-02

Intervention End Date

2020-07-31

Primary Outcomes

Primary Outcomes (end points)

Primary outcome: - Reduced TB-related stigma. Improved basic TB knowledge Improved Psychological problem related to TB patients: Stress, Depression and Anxiety. And Improved Anti- TB Treatment adherence.

Primary Outcomes (explanation)

Primary outcome: - Reduced TB-related stigma. Improved basic TB knowledge Improved Psychological problem related to TB patients: Stress, Depression and Anxiety. Improved Anti- TB Treatment adherence. And clarification of Myths and misconceptions of TB

Secondary Outcomes

Secondary Outcomes (end points)

Secondary Outcomes (explanation)

The secondary outcome of the intervention was as follows: Overall goal of behavioural change. i. Reduced TB stigma - a). Community TB stigma b). Patients TB stigma. ii. Improved to access effective TB treatment. iii. Empowerment of stigmatized individuals and enhanced. iv. Improved capacity building on basic knowledge of TB, and adjacent issues such as stigma, adherence and misconceptions regarding TB patients at HTBH. v. Improved adherence to TB treatment and treatment success. vi. As well as, clarified myths and misconceptions about TB. vii. Developed a guide to educating TB patients about TB stigma, understanding basics of TB knowledge, myths and misconceptions about TB, and adhering to their TB medication. Furthermore, Self-stigma and stigma intervention program outlined based on Health Belief Model (HBM), was effective in improving, psychological problems, stigma of tuberculosis, basic TB knowledge, patient TB treatment adherence, and myths and misconceptions regarding tuberculosis among TB patients. TB patient adherence education and the provision of ways to help patients overcome adherence barriers are effective approaches to improving medication adherence. Consequently, the stigma intervention program regarding tuberculosis among tuberculosis patients has shown evidence of effectiveness in improving psychological conditions and anti-tuberculosis treatment adherence among TB patients and therefore capable of
strengthening the current strategies being implemented in the prevention and control of tuberculosis in Somalia. Lastly, Overall, basic TB knowledge and treatment adherence regarding tuberculosis treatment had improved, on the other
hand, community TB stigma, and patients’ TB stigma perspectives were significantly decreased.

Experimental Design

This experimental study titled: Effectiveness of self-stigma reduction intervention program in improving psychological status and anti-tuberculosis treatment adherence among tuberculosis patients of Hargeisa tuberculosis hospital-Somalia- a randomized controlled trial, was used a technique of an experimentally designed with a randomized controlled trial (RCT). Conducted In one center (Single-center), 154 especially tuberculosis referral hospital. Firstly, we recruited research facilitators or assistances and we gave a two weeks training, the training exercise was attendedby five facilitators. The facilitators were chosen from among the hospital TB staff who were working for the TB control programme. The facilitator training includedthree males and two ladies. The training was based on a randomized controlledstudy demonstrating the effectiveness of a self-stigma reduction interventionprogramme cutting-edge enhancing psychological status and anti-tuberculosistreatment adherence among tuberculosis patients at Hargeisa TB hospital inSomalia.

Experimental Design Details

Randomization Method

(Abstracting) A simple random sampling method was used in selecting eligible participants using a computer-generated program www.randomizer.org (Urbaniak & Plous, 2015) giving each respondent an equal chance of being selected 305 respondents were randomly selected.
In details: Randomization and Allocation Concealment was done
i. Screening test was applied to the participants at the Outpatient Department
(OPD).
ii. Eligible patients for the study were recruited.
iii. Information sheets were distributed and consent forms were taken.
iv. Those who accepted to participate were sequentially randomly allocated in to the intervention or control group.

v. A computer number generator method was used to select the sample using the sample frame. vi. The 305 recruited participants were randomized used computer generator program www.randomizer.org and subsequently randomly assigned intointervention and control groups. vii. There were 155 participants in the intervention and 150 control groupsrespectively. The participants were allocated a code number to identify themonthe questionnaire in order to maintain confidentiality. viii. Allocation concealment was implemented to reduce the bias.
ix. Single-blind was applied as the participants were not aware of stigma intervention involvement or which group they belonged to and what will be done to their group.

Randomization Unit

This experimental study on a simply and sequentially randomized controlled trial was conducted in one center (Single-center), especially tuberculosis referral hospital of Hargeisa TB Hospital. there were no conducted cluster randomization.

Was the treatment clustered?

Experiment Characteristics

Sample size: planned number of clusters

Sample Size Determination
The hypothesis testing formula for 2 means was utilized (Lemeshow et al, 1990).1=mean stigma level (cue to action) score of TB patients in the intervention group=34(33-35) SD 6.5 (Toal et al., 2016). μ2 = mean stigma level (cue to action)score of respondents in the control group among TB patients = 32(31-33) SD 3.9 (Tola et al., 2016). Z1-/2 represents the standard error when = 0.05 (95% CI) = 1.96. Z1- = power-related standard error = 0.842 ( = 0.20)
Power (1-β) = 80%
Pooled standard deviation= 4.871
(Lemeshow, et al, 1990)
n = 2 x 4.871² [1.96 + 0.842] ²/
(34-32) ²
n = 305 with the addition of attrition rate. 155 IV /150 C. groups.
Respondents: Individual consent from the respondents. The experiment got consent from every respondent voluntarily, as individual consent from the respondents.

Sample size: planned number of observations

As we have sample size of 350 patients, the observations I made during the period of the intervention were 4478 number of observations

Sample size (or number of clusters) by treatment arms

The intervention and control groups were made from 305 pulmonary tuberculosis patients each 155 and 150 patients respectively, who were sequentially selected using simple random sampling with allocation concealment. Furthermore, daily pill DOTS were employed to assess compliance to their medication, and sputum examination and culture outcomes was used to determine therapy success. The intervention's effectiveness was evaluated using a mixed ANOVA on the reduction of stigma, improved knowledge, adherence to medication, and treatment-success. According to the ANOVA analysis, the Intervention self- stigma and stigma-associated TB-based HBM were significantly effective in the reduction of stigma, improving knowledge treatment adherence regarding tuberculosis patients of Hargeisa TB Hospital Somalia. Conclusion: Variables of the intervention ingredients were the utmost powerful components for decreasing TB stigma, improving basic TB knowledge medication adherence, treatment success, and misconceptions about tuberculosis.

Minimum detectable effect size for main outcomes (accounting for sample design and clustering)

Magnitude of the Intervention Effect. Table 4.20 presented the fixed coefficients of the outcome variables studied. The results showed that attending the intervention is expected to lead to higher total basic TB knowledge, TB Medication Adherence, and to lower TB stigma-Community and stigma TB patients Perspectives scores by 29.127%, 6.833%2.727%, and2.324% respectively. Additionally, the results also showed that the basic TB knowledge, TB stigma community and stigma TB patient perspectives are all significant differences among participants in the intervention and control group. moreover, A comparison of the results of pre-protocol and intention-to-treat analyses is presented in Table 4.22. For the five outcome variables studied, attrition had exaggerated the effect size of two variables (knowledge, adherence) were increased significantly, and that of two variables (TB Stigma community, and TB Stigma patient perspectives) were also decreased significantly. While the intervention showed significant effect on those variables.

Supporting Documents and Materials

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