HIV, Risky Sex Prevention
Conditions
Keywords
HIV, risky sex prevention, intervention
Brief summary
African American adolescent females are more likely to have sex at an early age, to have older sex partners that have had multiple sexual experiences, and are less likely to use a condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky sex behaviors of young African American women. African American girls at the greatest risk for contracting HIV are the ones that report that their partners could convince them to have sex and report trouble communicating their wishes related to sex. Thus far no intervention has addressed the disparate rate of HIV infection in young African American girls. This study is unique in promoting increases in racial pride as a component of empowerment to help African American girls self-protect against HIV. The study has the potential to empower young African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce their risk of contracting HIV.
Detailed description
This is a longitudinal intervention study with a study condition intervention and a control condition intervention. Potential participants will be invited to a recruitment meeting. If they choose to participate, they will be asked to sign informed consent or assent. There are 4 data collections for moms and girls - 1 after recruitment but before the start of the intervention, 1 at the end of the intervention (after the girls 12 week intervention), 1 three months after the end of the intervention (about 6 months after recruitment), and the final data collection 9 months after the end of the intervention (about 12 months from recruitment). Girls are asked to attend 12 group intervention sessions of about 2 hours each, once weekly, and then a final termination session that is followed by a celebration session to which their mothers are invited and then an evaluation session. Moms are asked to participate in 3 one hour education sessions over the 12 weeks that their daughters are in the weekly sessions, the celebration with their daughters, and then their evaluation session. Moms will also be asked to give their daughter empowering messages 5-7 times/week and girls asked to receive them. Finally, moms will be asked to receive calls from the study team once per month or 1 year to be asked about the empowering messages they have been sending their daughters.
Interventions
BEHAVIORALEducation, activities, empowerment, racial pride building
Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.
BEHAVIORALGeneral Health education, activities
Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).
Sponsors
University of North Carolina, Greensboro
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Mother Inclusion Criteria: * Must be 21 years or older. * Must be daughter's primary female guardian/caregiver and she lives with me at least 50% of the time. * Must understand spoken and written English. * Must be able to provide a phone number where they can be reached and will be able to maintain contact with researchers for one year after start of study. * Must be able to provide or arrange reliable transportation for their daughter after each session or data collection. Mother
Exclusion criteria
* Must not be incarcerated at the time of recruitment * Must not have a physical or mental health condition that may affect my or my daughter's participation in the study. Daughter Inclusion Criteria: * Must be in middle school (grades 6-8) at the time of recruitment. * Must be between the ages of 11-14 at the time of recruitment. * Must self-identify as Black, African-American, or a mixed race that includes black or African-American. * Must be able to understand written and spoken English. Daughter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Sex no Condom, Past 3 Months | 12 months | Any sex no condom, past 3 months |
| Drugs/Alcohol Use During Sex, Past 3 Months | 12 months | Drugs/Alcohol use during sex, past 3 months |
| Sex With Multiple Partners, Ever | 12 months | Sex with multiple partners, ever |
| Adolescent Sexual Activity Index | 12 months | Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, & Carter, 1999). A higher index value indicates more activity (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mother-Adolescent Communication: Open Family Communication (Girl) | 12 months | Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome. |
| Maternal Monitoring Scale (Girl) | 12 months | Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome. |
| Rosenberg Self-Esteem | 12 months | Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome. |
| Empowerment: Interpersonal | 12 months | Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions. |
| Empowerment: Relationship | 12 months | Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner. |
| Empowerment: Personal | 12 months | Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment. |
| Sexual Assertiveness: Refusal | 12 months | Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome). |
| Sexual Assertiveness: Prevent | 12 months | Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome). |
| Racial Pride | 12 months | Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome. |
| HIV Knowledge | 12 month | HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome. |
| Maternal Bond Scale | 12 months | Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome. |
| Mother-Teen Sexual Risk Communication | 12 months | Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Communication About Sex Self-Efficacy Scale | 12 months | Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome). |
| Maternal Monitoring Scale (Mother) | 12 months | Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome. |
| Mother Adolescent Communication: Open Family Communication (Mother) | 12 months | Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risky Sex Prevention-Daughters Education, activities, empowerment, racial pride building... | 51 |
| Healthy Behaviors-Daughters General health education, activities | 59 |
| Risky Sex Prevention-Mothers Activities, empowerment, communication..... | 48 |
| Healthy Behaviors-Mothers General health education, activities | 54 |
| Total | 212 |
Baseline characteristics
| Characteristic | Total | Healthy Behaviors-Daughters | Risky Sex Prevention-Daughters | Risky Sex Prevention-Mothers | Healthy Behaviors-Mothers |
|---|---|---|---|---|---|
| Adolescent Sexual Activity Index | 1.5 units on a scale STANDARD_DEVIATION 1.7 | 1.5 units on a scale STANDARD_DEVIATION 1.6 | 1.5 units on a scale STANDARD_DEVIATION 1.6 | — | — |
| Age, Continuous | 25.7 years STANDARD_DEVIATION 14.6 | 12.7 years STANDARD_DEVIATION 0.94 | 12.4 years STANDARD_DEVIATION 0.7 | 40.9 years STANDARD_DEVIATION 10.3 | 37.8 years STANDARD_DEVIATION 6.39 |
| Any sex no condom, past 3 months | 5 Participants | 1 Participants | 4 Participants | — | — |
| Communication about Sex Self-Efficacy | 55.8 units on a scale STANDARD_DEVIATION 5.2 | — | — | 55.8 units on a scale STANDARD_DEVIATION 5.3 | 55.8 units on a scale STANDARD_DEVIATION 5.2 |
| Current Grade 6th grade | 43 Participants | 21 Participants | 22 Participants | — | — |
| Current Grade 7th grade | 44 Participants | 21 Participants | 23 Participants | — | — |
| Current Grade 8th grade | 23 Participants | 17 Participants | 6 Participants | — | — |
| Drugs/Alcohol use during sex, past 3 months | 2 Participants | 0 Participants | 2 Participants | — | — |
| Empowerment: Interpersonal | 9.3 units on a scale STANDARD_DEVIATION 2.4 | 9.2 units on a scale STANDARD_DEVIATION 2.6 | 9.4 units on a scale STANDARD_DEVIATION 2.2 | — | — |
| Empowerment: Personal | 18.4 units on a scale STANDARD_DEVIATION 3.5 | 18.2 units on a scale STANDARD_DEVIATION 4.2 | 18.5 units on a scale STANDARD_DEVIATION 2.6 | — | — |
| Empowerment: Relationship | 8.0 units on a scale STANDARD_DEVIATION 3.9 | 7.9 units on a scale STANDARD_DEVIATION 3.8 | 8.0 units on a scale STANDARD_DEVIATION 4 | — | — |
| HIV Knowledge | 9.5 units on a scale STANDARD_DEVIATION 2.9 | 9.1 units on a scale STANDARD_DEVIATION 3.2 | 9.9 units on a scale STANDARD_DEVIATION 2.5 | — | — |
| Maternal Bond Scale | 27.2 units on a scale STANDARD_DEVIATION 5.2 | 27.9 units on a scale STANDARD_DEVIATION 4.5 | 26.3 units on a scale STANDARD_DEVIATION 5.9 | — | — |
| Maternal Monitoring Scale Daughters only | 35.0 units on a scale STANDARD_DEVIATION 4.2 | 35.2 units on a scale STANDARD_DEVIATION 4.3 | 34.8 units on a scale STANDARD_DEVIATION 4.2 | — | — |
| Maternal Monitoring Scale Mothers only | 37.4 units on a scale STANDARD_DEVIATION 2.4 | — | — | 37.4 units on a scale STANDARD_DEVIATION 2.6 | 37.4 units on a scale STANDARD_DEVIATION 2.2 |
| Mother-Adolescent Communication: Open Family Communication Daughters only | 39.4 units on a scale STANDARD_DEVIATION 8.4 | 40.6 units on a scale STANDARD_DEVIATION 7.7 | 38.1 units on a scale STANDARD_DEVIATION 9 | — | — |
| Mother-Adolescent Communication: Open Family Communication Mothers only | 41.1 units on a scale STANDARD_DEVIATION 5.3 | — | — | 41.1 units on a scale STANDARD_DEVIATION 5.2 | 41.2 units on a scale STANDARD_DEVIATION 5.3 |
| Mother-Teen Sexual Risk Communication | 24.4 units on a scale STANDARD_DEVIATION 8.8 | 24.2 units on a scale STANDARD_DEVIATION 9.1 | 24.5 units on a scale STANDARD_DEVIATION 8.6 | — | — |
| Race/Ethnicity, Customized Race/Ethnicity African-American | 164 Participants | 48 Participants | 30 Participants | 38 Participants | 48 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mixed | 40 Participants | 11 Participants | 21 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Racial Pride | 21.2 units on a scale STANDARD_DEVIATION 4.3 | 21.3 units on a scale STANDARD_DEVIATION 4.3 | 21.0 units on a scale STANDARD_DEVIATION 4.2 | — | — |
| Region of Enrollment United States | 212 participants | 59 participants | 51 participants | 48 participants | 54 participants |
| Rosenberg Self-Esteem | 21.5 units on a scale STANDARD_DEVIATION 5 | 21.8 units on a scale STANDARD_DEVIATION 4.2 | 21.0 units on a scale STANDARD_DEVIATION 5.9 | — | — |
| Sex: Female, Male Female | 212 Participants | 59 Participants | 51 Participants | 48 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sexual Assertiveness: Prevent subscale | 26.2 units on a scale STANDARD_DEVIATION 4.7 | 25.5 units on a scale STANDARD_DEVIATION 4.9 | 27.0 units on a scale STANDARD_DEVIATION 4.3 | — | — |
| Sexual Assertiveness: Refusal subscale | 23.6 units on a scale STANDARD_DEVIATION 5 | 23.9 units on a scale STANDARD_DEVIATION 4.9 | 23.3 units on a scale STANDARD_DEVIATION 5.2 | — | — |
| Sex with multiple partners, ever | 3 Participants | 2 Participants | 1 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 59 | 0 / 48 | 0 / 54 |
| other Total, other adverse events | 0 / 51 | 0 / 59 | 0 / 48 | 0 / 54 |
| serious Total, serious adverse events | 0 / 51 | 0 / 59 | 0 / 48 | 0 / 54 |
Outcome results
Primary
Adolescent Sexual Activity Index
Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, & Carter, 1999). A higher index value indicates more activity (worse outcome).
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Adolescent Sexual Activity Index | Baseline / Pre-Interveniton | 1.39 score on a scale | Standard Error 0.19 |
| Risky Sex Prevention | Adolescent Sexual Activity Index | At 12 months | 2.12 score on a scale | Standard Error 0.33 |
| Healthy Behaviors | Adolescent Sexual Activity Index | Baseline / Pre-Interveniton | 1.45 score on a scale | Standard Error 0.19 |
| Healthy Behaviors | Adolescent Sexual Activity Index | At 12 months | 1.90 score on a scale | Standard Error 0.3 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.62count GEE
Primary
Any Sex no Condom, Past 3 Months
Any sex no condom, past 3 months
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Any Sex no Condom, Past 3 Months | Baseline / Pre-Interveniton | 7.1 logistic GEE predicted probability as % | Standard Error 3.6 |
| Risky Sex Prevention | Any Sex no Condom, Past 3 Months | At 12 months | 8.4 logistic GEE predicted probability as % | Standard Error 4.3 |
| Healthy Behaviors | Any Sex no Condom, Past 3 Months | Baseline / Pre-Interveniton | 1.3 logistic GEE predicted probability as % | Standard Error 1.3 |
| Healthy Behaviors | Any Sex no Condom, Past 3 Months | At 12 months | 2.4 logistic GEE predicted probability as % | Standard Error 1.7 |
Comparison: Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.15logistic GEE
Primary
Drugs/Alcohol Use During Sex, Past 3 Months
Drugs/Alcohol use during sex, past 3 months
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Drugs/Alcohol Use During Sex, Past 3 Months | Baseline / Pre-Interveniton | 4.4 logistic GEE predicted probability as % | Standard Error 3.2 |
| Risky Sex Prevention | Drugs/Alcohol Use During Sex, Past 3 Months | At 12 months | 1.3 logistic GEE predicted probability as % | Standard Error 1.4 |
| Healthy Behaviors | Drugs/Alcohol Use During Sex, Past 3 Months | Baseline / Pre-Interveniton | 0.0 logistic GEE predicted probability as % | Standard Error 0 |
| Healthy Behaviors | Drugs/Alcohol Use During Sex, Past 3 Months | At 12 months | 5.1 logistic GEE predicted probability as % | Standard Error 3.7 |
Comparison: Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.29logistic GEE
Primary
Sex With Multiple Partners, Ever
Sex with multiple partners, ever
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Sex With Multiple Partners, Ever | Baseline / Pre-Interveniton | 0.0 logistic GEE predicted probability as % | Standard Error 0 |
| Risky Sex Prevention | Sex With Multiple Partners, Ever | At 12 months | 1.0 logistic GEE predicted probability as % | Standard Error 0.9 |
| Healthy Behaviors | Sex With Multiple Partners, Ever | Baseline / Pre-Interveniton | 0.0 logistic GEE predicted probability as % | Standard Error 0 |
| Healthy Behaviors | Sex With Multiple Partners, Ever | At 12 months | 2.2 logistic GEE predicted probability as % | Standard Error 1.3 |
Comparison: Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.47logistic GEE
Secondary
Empowerment: Interpersonal
Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Empowerment: Interpersonal | Baseline / Pre-Interveniton | 14.7 score on a scale | Standard Error 0.32 |
| Risky Sex Prevention | Empowerment: Interpersonal | At 12 months | 14.2 score on a scale | Standard Error 0.35 |
| Healthy Behaviors | Empowerment: Interpersonal | Baseline / Pre-Interveniton | 14.8 score on a scale | Standard Error 0.36 |
| Healthy Behaviors | Empowerment: Interpersonal | At 12 months | 15.2 score on a scale | Standard Error 0.3 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.05count GEE
Secondary
Empowerment: Personal
Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Empowerment: Personal | At 12 months | 18.2 score on a scale | Standard Error 0.4 |
| Risky Sex Prevention | Empowerment: Personal | Baseline / Pre-Intervention | 18.6 score on a scale | Standard Error 0.44 |
| Healthy Behaviors | Empowerment: Personal | At 12 months | 18.3 score on a scale | Standard Error 0.46 |
| Healthy Behaviors | Empowerment: Personal | Baseline / Pre-Intervention | 18.3 score on a scale | Standard Error 0.46 |
Secondary
Empowerment: Relationship
Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Empowerment: Relationship | At 12 months | 17.1 score on a scale | Standard Error 0.52 |
| Risky Sex Prevention | Empowerment: Relationship | Baseline / Pre-Intervention | 16.0 score on a scale | Standard Error 0.56 |
| Healthy Behaviors | Empowerment: Relationship | At 12 months | 16.6 score on a scale | Standard Error 0.51 |
| Healthy Behaviors | Empowerment: Relationship | Baseline / Pre-Intervention | 15.0 score on a scale | Standard Error 0.66 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.5count GEE
Secondary
HIV Knowledge
HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.
Time frame: 12 month
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | HIV Knowledge | Baseline / Pre-Interveniton | 9.8 score on a scale | Standard Error 0.31 |
| Risky Sex Prevention | HIV Knowledge | At 12 months | 13.1 score on a scale | Standard Error 0.38 |
| Healthy Behaviors | HIV Knowledge | Baseline / Pre-Interveniton | 8.5 score on a scale | Standard Error 0.56 |
| Healthy Behaviors | HIV Knowledge | At 12 months | 10.4 score on a scale | Standard Error 0.35 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: <0.001linear GEE
Secondary
Maternal Bond Scale
Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Maternal Bond Scale | Baseline / Pre-Interveniton | 26.9 score on a scale | Standard Error 0.78 |
| Risky Sex Prevention | Maternal Bond Scale | At 12 months | 26.8 score on a scale | Standard Error 0.63 |
| Healthy Behaviors | Maternal Bond Scale | Baseline / Pre-Interveniton | 27.8 score on a scale | Standard Error 0.62 |
| Healthy Behaviors | Maternal Bond Scale | At 12 months | 28.9 score on a scale | Standard Error 0.65 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.02linear GEE
Secondary
Maternal Monitoring Scale (Girl)
Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Maternal Monitoring Scale (Girl) | Baseline / Pre-Interveniton | 34.4 score on a scale | Standard Error 0.76 |
| Risky Sex Prevention | Maternal Monitoring Scale (Girl) | At 12 months | 34.7 score on a scale | Standard Error 0.67 |
| Healthy Behaviors | Maternal Monitoring Scale (Girl) | Baseline / Pre-Interveniton | 35.0 score on a scale | Standard Error 0.5 |
| Healthy Behaviors | Maternal Monitoring Scale (Girl) | At 12 months | 35.1 score on a scale | Standard Error 0.78 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.7count GEE
Secondary
Mother-Adolescent Communication: Open Family Communication (Girl)
Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Mother-Adolescent Communication: Open Family Communication (Girl) | Baseline / Pre-Interveniton | 39.1 score on a scale | Standard Error 1.1 |
| Risky Sex Prevention | Mother-Adolescent Communication: Open Family Communication (Girl) | At 12 months | 37.8 score on a scale | Standard Error 1.3 |
| Healthy Behaviors | Mother-Adolescent Communication: Open Family Communication (Girl) | Baseline / Pre-Interveniton | 39.5 score on a scale | Standard Error 1.6 |
| Healthy Behaviors | Mother-Adolescent Communication: Open Family Communication (Girl) | At 12 months | 39.2 score on a scale | Standard Error 1.2 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.45count GEE
Secondary
Mother-Teen Sexual Risk Communication
Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Mother-Teen Sexual Risk Communication | Baseline / Pre-Interveniton | 22.8 score on a scale | Standard Error 1.4 |
| Risky Sex Prevention | Mother-Teen Sexual Risk Communication | At 12 months | 25.4 score on a scale | Standard Error 1.1 |
| Healthy Behaviors | Mother-Teen Sexual Risk Communication | Baseline / Pre-Interveniton | 22.0 score on a scale | Standard Error 1.6 |
| Healthy Behaviors | Mother-Teen Sexual Risk Communication | At 12 months | 26.1 score on a scale | Standard Error 1.4 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.67linear GEE
Secondary
Racial Pride
Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Racial Pride | Baseline / Pre-Interveniton | 20.9 score on a scale | Standard Error 0.71 |
| Risky Sex Prevention | Racial Pride | At 12 months | 22.7 score on a scale | Standard Error 0.52 |
| Healthy Behaviors | Racial Pride | Baseline / Pre-Interveniton | 21.2 score on a scale | Standard Error 0.54 |
| Healthy Behaviors | Racial Pride | At 12 months | 22.3 score on a scale | Standard Error 0.56 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.63count GEE
Secondary
Rosenberg Self-Esteem
Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Rosenberg Self-Esteem | Baseline / Pre-Interveniton | 20.6 score on a scale | Standard Error 0.88 |
| Risky Sex Prevention | Rosenberg Self-Esteem | At 12 months | 21.8 score on a scale | Standard Error 1 |
| Healthy Behaviors | Rosenberg Self-Esteem | Baseline / Pre-Interveniton | 21.7 score on a scale | Standard Error 0.64 |
| Healthy Behaviors | Rosenberg Self-Esteem | At 12 months | 22.8 score on a scale | Standard Error 0.9 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.42linear GEE
Secondary
Sexual Assertiveness: Prevent
Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Sexual Assertiveness: Prevent | Baseline / Pre-Intervention | 26.8 score on a scale | Standard Error 0.68 |
| Risky Sex Prevention | Sexual Assertiveness: Prevent | At 12 months | 27.1 score on a scale | Standard Error 0.71 |
| Healthy Behaviors | Sexual Assertiveness: Prevent | Baseline / Pre-Intervention | 25.8 score on a scale | Standard Error 0.68 |
| Healthy Behaviors | Sexual Assertiveness: Prevent | At 12 months | 26.4 score on a scale | Standard Error 0.59 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.46count GEE
Secondary
Sexual Assertiveness: Refusal
Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Sexual Assertiveness: Refusal | Baseline / Pre-Interveniton | 23.2 score on a scale | Standard Error 0.87 |
| Risky Sex Prevention | Sexual Assertiveness: Refusal | At 12 months | 25.0 score on a scale | Standard Error 0.98 |
| Healthy Behaviors | Sexual Assertiveness: Refusal | Baseline / Pre-Interveniton | 24.4 score on a scale | Standard Error 0.7 |
| Healthy Behaviors | Sexual Assertiveness: Refusal | At 12 months | 25.3 score on a scale | Standard Error 0.77 |
Comparison: Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.86count GEE
Other Pre-specified
Communication About Sex Self-Efficacy Scale
Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Communication About Sex Self-Efficacy Scale | Baseline / Pre-Interveniton | 56.0 score on a scale | Standard Error 0.74 |
| Risky Sex Prevention | Communication About Sex Self-Efficacy Scale | At 12 months | 57.8 score on a scale | Standard Error 0.59 |
| Healthy Behaviors | Communication About Sex Self-Efficacy Scale | Baseline / Pre-Interveniton | 55.5 score on a scale | Standard Error 0.92 |
| Healthy Behaviors | Communication About Sex Self-Efficacy Scale | At 12 months | 58.3 score on a scale | Standard Error 0.31 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.43linear GEE
Other Pre-specified
Maternal Monitoring Scale (Mother)
Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Maternal Monitoring Scale (Mother) | Baseline / Pre-Interveniton | 37.1 score on a scale | Standard Error 0.44 |
| Risky Sex Prevention | Maternal Monitoring Scale (Mother) | At 12 months | 37.9 score on a scale | Standard Error 0.29 |
| Healthy Behaviors | Maternal Monitoring Scale (Mother) | Baseline / Pre-Interveniton | 37.3 score on a scale | Standard Error 0.35 |
| Healthy Behaviors | Maternal Monitoring Scale (Mother) | At 12 months | 37.4 score on a scale | Standard Error 0.39 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.29linear GEE
Other Pre-specified
Mother Adolescent Communication: Open Family Communication (Mother)
Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.
Time frame: 12 months
Population: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Risky Sex Prevention | Mother Adolescent Communication: Open Family Communication (Mother) | Baseline / Pre-Interveniton | 41.4 score on a scale | Standard Error 0.8 |
| Risky Sex Prevention | Mother Adolescent Communication: Open Family Communication (Mother) | At 12 months | 41.0 score on a scale | Standard Error 0.93 |
| Healthy Behaviors | Mother Adolescent Communication: Open Family Communication (Mother) | Baseline / Pre-Interveniton | 41.2 score on a scale | Standard Error 0.76 |
| Healthy Behaviors | Mother Adolescent Communication: Open Family Communication (Mother) | At 12 months | 41.5 score on a scale | Standard Error 0.8 |
Comparison: Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.p-value: 0.7linear GEE