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Completed

NCT Number: NCT03762187

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

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.

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Key information

Conditions

Self-affirmation Plus Positive Living Counseling Counseling

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

-

Treatment and study plan

Self-affirmation

Behavioral

Individuals select important values and then write about why that value is important to them.

Positive living counseling

Behavioral

Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: 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".

  2. Intrusion subscale of impact of events scale

    Time frame: 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.

  3. Concerns about dying

    Time frame: 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.

  4. Distressing emotions related to HIV

    Time frame: 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.

  5. Future behavioral intentions

    Time frame: 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 outcomes

  1. Physical health measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Santa Barbara

Other

Collaborators

  • Fulbright
  • Ministry of Health, Lesotho

Registry information

Official study title

Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2018
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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