Trial Outcomes & Findings for Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV (NCT NCT05383755)

Adolescents and caregivers were recruited with assistance from providers at health clinics.

Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative measure adapted for this study; overall objective quality (engagement, functionality, aesthetics, information); self-report survey items assessing overall objective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App objective quality mean scores Min=4.25, Max=5.00. Higher scores mean perception of higher quality.

Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative data; overall subjective quality; self-report survey items assessing overall subjective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App subjective quality mean scores: Min=3.67, Max=5.00. Higher scores indicate perception of higher quality.

Aim 1 Phase 3. Change in perception of experienced stigma (e.g., "Someone stopped being my friend.") (Never, Once or twice, Several times, Most of the time)(14 summed items; scale score range 0-42 with higher values indicating more stigma)

Aim 1 Phase 3. Change in internalized pregnancy-related stigma among adolescents. Example item:"Becoming pregnant and having a baby as a teen makes me feel ashamed and bad about myself;" Response Options: Agree, Disagree) (4 summed items; scale score range 0-4 with higher values indicating more stigma). Adapted for pregnancy-related stigma from the Internalized AIDS-Related Stigma Scale.

Aim 1 Phase 3. Change in the respondent's confidence in making an effective decision to disclose HIV status to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.

Aim 1 Phase 3. Change in respondent's confidence in making an effective decision to disclose pregnancy to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are pregnant?" (1 item, 11-pt scale: 0-10; 0=cannot do, 10=certain can do; higher scores mean higher confidence). Adapted from self-efficacy to make an effective decision to disclose HIV status.

Measures respondent's confidence in knowing when it is safe to disclose HIV status to a family member. Question Item: "How confident are you that you could know whether it was safe to tell a family member parent that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.

Change in internalized HIV-related stigma (or self-stigma) among adolescents (e.g., "You feel guilty that you are HIV positive;" Response Options: Agree, Disagree). (4 summed items; scale score range 0-4 with higher values indicating more stigma)

Change in respondent's use of avoidance, denial, and wishful thinking to cope with the stigma of HIV/AIDS (e.g. "I try not to think about the stigma of living with HIV. I try to forget all about it;" Response Options: Not at all, A little, Some, A lot). (4 summed items; score range 4-16 with higher values indicating poorer coping)

Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent directly informs her caregiver that she is pregnant and/or living with HIV.

Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent makes no direct effort to reveal her status.

Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.

Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.

Data were collected during Aim 1 Phase 1. Measure Definition: The disclosure occurs though it was unintended by the adolescent.

Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV-related stigma is worse than stigma associated with pregnancy.

Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that pregnancy-related stigma is worse than stigma associated with HIV.

Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV- and pregnancy-related stigma are equally bad.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who noted having not received support (e.g., money, food, clothing, encouragement, emotional support, etc.) that they needed.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing their pregnancies.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing their pregnancies.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing HIV.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing HIV.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed their pregnancy.

Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed HIV.

Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of the interview, their primary caregiver knew about their pregnancy.

Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of their interview, their primary caregiver knew about their HIV status.

Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1, Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.

Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who liked the idea of developing a similar digital intervention (i.e., an "App") for caregivers.

Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.

Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.

Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged via radio advertisements as an alternative to using an App.

Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a healthcare setting as an alternative to using an App.