ClinicalTrials.gg
CompletedNCT03762187Updated Dec 7, 2023

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

An interventional study of Self-affirmation and Positive living counseling in Self-affirmation Plus Positive Living Counseling and Counseling, sponsored by University of California, Santa Barbara. Completed. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by University of California, Santa Barbara · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Sep 2014, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
389
Allocation
Randomized
Sex
All
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Study 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.

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Conditions studied

  • Self-affirmation Plus Positive Living Counseling
  • Counseling
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In context

Lead sponsor

University of California, Santa Barbara is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Care provider)
Enrollment
389 participants (actual)

Study arms

  • Experimental
    Self-affirmation

    Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.

    Behavioral: Self-affirmation · Behavioral: Positive living counseling

  • Active comparator
    Positive living counseling

    Participants completed the standard counseling provided by the clinic (treatment as usual control condition).

    Behavioral: Positive living counseling

Interventions

  • BehavioralSelf-affirmation

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

  • BehavioralPositive living counseling

    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.

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What researchers measure

Primary outcomes

  1. Perceived Stress Scale

    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".

    Time frame: Post-intervention survey conducted immediately after intervention session

  2. Intrusion subscale of impact of events scale

    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.

    Time frame: Post-intervention survey conducted immediately after intervention session

  3. Concerns about dying

    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.

    Time frame: Post-intervention survey conducted immediately after intervention session

  4. Distressing emotions related to HIV

    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.

    Time frame: Post-intervention survey conducted immediately after intervention session

  5. Future behavioral intentions

    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".

    Time frame: Post-intervention survey conducted immediately after intervention session

Secondary outcomes

  1. Physical health measures

    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.

    Time frame: Post-intervention survey conducted immediately after intervention session

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2014 to primary completion in Jan 2015, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2018
First posted
Dec 3, 2018
StartActual
Sep 1, 2014
Primary completionActual
Jan 31, 2015
CompletionActual
Jan 31, 2015
Last update
Dec 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03762187
Lead sponsor
University of California, Santa Barbara
Collaborators
Fulbright, Ministry of Health, Lesotho
Responsible party
David Sherman (Professor, University of California, Santa Barbara) — Principal investigator
First posted
Dec 3, 2018
Start date
Sep 1, 2014
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015
Last update
Dec 7, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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