A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho

Not Applicable

Completed

• Conditions: Self-affirmation Plus Positive Living Counseling; Counseling
• Interventions: Behavioral: Self-affirmation; Behavioral: Positive living counseling

• Registration Number: NCT03762187
• Lead Sponsor: University of California, Santa Barbara

Brief Summary

This study is interested in the stress associated with being HIV positive and looking at ways to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats and stressors: the burden of illness, loss of work, stigmatization, and the chance of death. The study investigates the use of self-affirmation to reduce some of these threats and stressors. Self-affirmation may helping people to cope with these threats and stressors by reminding individuals of other valued aspects of themselves, thus reducing the impact, both psychologically and physiologically, of these threats. Experimentally induced affirmations in which individuals are asked to write about values that are important to the self have been shown to reduce physiological stress among healthy student populations (Sherman, Bunyan, Creswell, \& Jaremka, 2009).

This research will be conducted in collaboration with the global health organizations, PSI who is already providing counseling to those living with HIV on how to reduce the spread of HIV and how to live a healthy life with HIV. These counseling sessions take place at local clinics and hospitals while individuals are waiting to be seen for treatment and are completely voluntary.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2015-01-31
• Study Completion: 2015-01-31
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

• HIV+
• A CD4 count of less than or equal to 500 cells/mm3 or have significant symptomatology and HIV co-illness (WHO HIV clinical stage 3 or 4) to be eligible to start antiretroviral therapy

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Self-affirmation	Self-affirmation	Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.
Self-affirmation	Positive living counseling	Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.
Positive living counseling	Positive living counseling	Participants completed the standard counseling provided by the clinic (treatment as usual control condition).

Primary Outcome Measures

Name	Time	Method
Concerns about dying	Post-intervention survey conducted immediately after intervention session	Participants indicated to what extent they were currently concerned about dying using a single item, "Today, I find myself worrying about dying". Participants indicated their agreement with that statement using a 6-point Likert scale from 1= "Very Much Disagree" to 6 = "Very Much Agree", with higher numbers indicating greater worries about dying.
Intrusion subscale of impact of events scale	Post-intervention survey conducted immediately after intervention session	Participants completed questions regarding their current experience of intrusive thoughts related to HIV adapted from the intrusion subscale of the Impact of Events Scale (Horowitz, Wilner, \& Alvarez, 1979). This measure was designed to assess distress caused by traumatic events. The impact of events scale is a well-validated measure that is often used (in combination with the DSM-IV) to assess post-traumatic stress disorder. In essence, this measure was designed to assess how traumatized participants felt by their HIV diagnosis. Participants rated their agreement with statements such as "Today, any reminder of HIV brings back feelings about it" and "Today, I think about HIV even when I don't mean to" using a 1= "Very Much Disagree" to 6 = "Very Much Agree" scale.
Perceived Stress Scale	Post-intervention survey conducted immediately after intervention session	Participants were asked to complete an abbreviated version of the Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983), a well validated measure of participants' current stress. For this scale, participants are asked to rate their agreement with statements such as "Today, I feel nervous and stressed" or "Today I feel that difficulties are piling up so high that I cannot overcome them" using a 6-point Likert scale anchored from 1= "Very Much Disagree" to 6 = "Very Much Agree".
Distressing emotions related to HIV	Post-intervention survey conducted immediately after intervention session	Participants indicated to what extent they were experiencing distressing emotions related to HIV on a 5-point Likert scale from 1="Never" to 5="Always", with higher numbers indicating a greater frequency of distressing emotions related to HIV.
Future behavioral intentions	Post-intervention survey conducted immediately after intervention session	Participants were asked to rate their agreement with statements regarding their future intentions to engage in positive living behaviors using a 6-point Likert scale from from 1= "Very Much Disagree" to 6 = "Very Much Agree". In particular, participants were asked to indicate their intention to use condoms in the future by indicating their agreement with statements such as, "If a sexual partner didn't want to use condoms, we would have sex without using condoms" or "It is a hassle to use condoms". Participants indicated their intention to take their medications by indicating their agreement with the statements, "I will take my medication regularly" and "I have trouble taking my medication as I am supposed to (reversed)". Additionally, participants indicated their intention to have non-concurrent sexual partners using the statement "I will only have one sexual relationship at a time".

Secondary Outcome Measures

Name	Time	Method
Physical health measures	Post-intervention survey conducted immediately after intervention session	In order to assess participants' baseline self-reported health, participants completed the general health subscale of the RAND 36-item Short Form Health Survey, a well-validated measure designed to assess health that is utilized by many health organizations, including Medicare, to assess and monitor healthcare outcomes. Participants were asked to answer five questions regarding their current health using a 5-point Likert scale.