HIV
Conditions
Keywords
HIV prevention, HIV treatment, Zambia
Brief summary
The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented where AGYW participants, stratified by age group and HIV status, will be randomized based on their residence within the six study clinic catchment areas, into the following intervention arms: no intervention, the SHIELD intervention, and the SHIELD intervention and IWC clinics.
Detailed description
The SHIELD intervention aims to improve HIV prevention and care for adolescent girls and young women (AGYW) in Zambia. It is based on social cognitive theory and includes a program for AGYW to increase knowledge, skills, and self-efficacy, as well as a program for family members to increase social support. The intervention also incorporates youth clubs facilitated by peer navigators and integrated wellness clinics (IWC) for sexual and reproductive health services. It will be tailored for five distinct groups based on age and HIV status, with modules covering HIV prevention and treatment, wellness, sexual health, stigma reduction, and healthcare access. IWC clinics will be established in existing government health facilities, following a model similar to cervical cancer screening clinics. Standard operating procedures (SOPs) will be developed for HIV, HPV vaccination, and sexual and reproductive health services. Time and motion methodology will monitor AGYW clinic visits to identify areas for improvement. To establish a sampling frame, the study team will identify six clinics in Lusaka, map neighborhoods within the selected clinic catchment areas, and recruit AGYW through household visits by peer navigators. The HIV-/u cohort will include females aged 10-20 years with self-reported HIV-negative or unknown status. They must not be pregnant or planning pregnancy, be willing to sign a medical records release, plan to reside in the area for 18 months, and not be part of other formative research activities. The study will recruit 1,000 HIV-/u AGYW, with equal numbers in age ranges 10-12, 13-15, and 16-20. The HIV+ cohort will consist of females aged 16-24 years, diagnosed with HIV within the past 3 years, and meeting the same additional criteria as the HIV-/u cohort. The study will enroll 800 HIV+ AGYW, with equal representation among 16-20 and 21-24 age groups. AGYW will be encouraged to select caregivers who will participate in some of the education sessions. The role of the caregiver is to support AGYW. Primary and secondary outcomes will be reported for AGYW only. Data collection will use electronic tablets with pre-loaded software and instruments in multiple languages. Voice-enabled components and self-administration options will be available for sensitive questions. Instruments will be pretested with AGYW and caregivers. The study team will abstract data from clinic records with support from the Zambian Ministry of Health, conducting pilot data abstraction and staff training to ensure high-quality data for the study. Key aspects of the intervention include tailored education modules for AGYW and caregivers, youth clubs led by peer navigators, and integrated wellness clinics offering comprehensive sexual and reproductive health services. The SHIELD study aims to improve HIV prevention and care for AGYW in Zambia by addressing knowledge, skills, self-efficacy, social support, and healthcare access through a comprehensive, theory-based intervention. By combining education, social support, and improved healthcare services, the researchers hope to make significant strides in reducing HIV transmission and improving health outcomes for adolescent girls and young women in Zambia.
Interventions
BEHAVIORALSHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)
The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for caregivers to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.
OTHERIntegrated wellness care (IWC) clinics
IWC clinics will be created within health facilities where AGYWs can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and HPV vaccination in a youth-friendly environment.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Population Council
University of North Carolina, Chapel Hill
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Based on their residence in the catchment areas of the six selected study clinics, AGYW participants, stratified by age group and HIV status, will be randomized into the following three treatment arms: no intervention, the SHIELD intervention, and the SHIELD intervention and IWC clinics. The sample size was calculated assuming conventional specifications (power = .80, alpha = .05, two-sided tests) and based on the primary endpoints.
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
HIV negative or unknown cohort * Female * 10 to 20 years of age * self-report HIV status as negative or unknown (no HIV testing within the past 6 months * not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months * is willing to sign a release for medical records (to obtain clinic data on service use) * plans to reside in the current location for the next 18 months * has not been part of the other planned formative research activities HIV positive cohort * Female * 16 to 24 years of age * diagnosed with HIV within the past 3 years or newly diagnosed at the time of the study * not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months * is willing to sign a release for medical records (to obtain clinic data on service use) * plans to reside in the current location for the next 18 months * has not been part of the other planned formative research activities
Exclusion criteria
* pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing | 6 months | Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months. |
| HIV-/u Proportion Tested for HIV in the Past 6 Months | 12 months | Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months. |
| Retention in Care | 12 months | HIV+ cohort proportion with at least one visit during the 12-months follow-up. Data were not collected from any participant due to COVID 19 pandemic and associated restrictions, and will not be collected in the future. |
| HIV+ Proportion With Undetectable Viral Load at 12 Months | At 12 months since study initiation | Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linkages to HIV Care - Enrollment at HIV Clinic | 6 months | Proportion enrolled at an HIV clinic in ≤ 30 days |
| HIV Risk Behavior - Delay in First Intercourse | Baseline | Self-reported age of first intercourse among HIV-/u cohort. |
| Adherence to ART | 6 months | AGYW living with HIV who self-reported Excellent medication adherence. |
| Linkages to HIV Care - ART Initiation | 6 months | Proportion with ART initiated in ≤ 90 days |
| HIV Risk Behavior - Reduction in Sexual Partners | Baseline | Self reported number of casual partners in the last 3 months among HIV-/u cohort. |
| HIV Risk Behavior - Increases in Condom Use | Baseline | HIV-/u AGYW who reported always using condoms with casual partners in past 3 months. |
| HIV Early Detection | 12 months | HIV-/u proportion with HIV identified through voluntary testing. |
Countries
Zambia
Participant flow
Recruitment details
Recruited adolescent and young women (AGYWs) from 6 clinic sites in the Lusaka, Zambia area. AGYWs were the main participants in the clinical trial and caregivers were recruited in a support capacity for AGYWs.
Pre-assignment details
Assigned to HIV+ or HIV-/u depending on their HIV status at the time of enrollment.
Participants by arm
| Arm | Count |
|---|---|
| AGYW Control One-time Education (AGYW) | 375 |
| AGYW SHIELD Only SHIELD Intervention (AGYW) | 372 |
| AGYW SHIELD + IWC Clinic SHIELD Intervention and Integrated Wellness Clinic (AGYW) | 376 |
| Caregiver Control Caregivers appointed by those in AGYW Control. | 348 |
| Caregiver SHIELD Only Caregivers appointed by those in AGYW SHIELD Intervention. | 347 |
| Caregiver SHIELD + IWC Clinic Caregivers appointed by those in AGYW SHIELD Intervention and Integrated Wellness Clinic. | 332 |
| Total | 2,150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 3 | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Health Issues | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 6 | 54 | 3 | 32 | 5 | 44 | 0 | 31 | 8 | 36 | 5 | 41 |
| Overall Study | Relocated | 11 | 0 | 16 | 0 | 14 | 0 | 16 | 0 | 14 | 0 | 15 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Caregiver SHIELD + IWC Clinic | Caregiver SHIELD Only | AGYW Control | Caregiver Control | AGYW SHIELD + IWC Clinic | AGYW SHIELD Only |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 610 Participants | 0 Participants | 0 Participants | 219 Participants | 0 Participants | 194 Participants | 197 Participants |
| Age, Categorical >=65 years | 22 Participants | 8 Participants | 7 Participants | 0 Participants | 7 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1518 Participants | 324 Participants | 340 Participants | 156 Participants | 341 Participants | 182 Participants | 175 Participants |
| Age, Continuous | 27.2 years STANDARD_DEVIATION 12.8 | 36.6 years STANDARD_DEVIATION 11.9 | 37.7 years STANDARD_DEVIATION 11.8 | 17.9 years STANDARD_DEVIATION 3.8 | 37.3 years STANDARD_DEVIATION 11.3 | 18.0 years STANDARD_DEVIATION 3.8 | 18.1 years STANDARD_DEVIATION 3.8 |
| Age, Customized HIV+ | 29.3 years STANDARD_DEVIATION 12.3 | 38.5 years STANDARD_DEVIATION 12.2 | 39.2 years STANDARD_DEVIATION 11.7 | 20.8 years STANDARD_DEVIATION 2.5 | 39.8 years STANDARD_DEVIATION 11.7 | 21.0 years STANDARD_DEVIATION 2.3 | 21.0 years STANDARD_DEVIATION 2.5 |
| Age, Customized HIV-/U | 25.5 years STANDARD_DEVIATION 13 | 35.3 years STANDARD_DEVIATION 11.4 | 36.6 years STANDARD_DEVIATION 11.7 | 15.3 years STANDARD_DEVIATION 2.7 | 35.4 years STANDARD_DEVIATION 10.7 | 15.5 years STANDARD_DEVIATION 2.9 | 15.6 years STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2150 Participants | 332 Participants | 347 Participants | 375 Participants | 348 Participants | 376 Participants | 372 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV Status HIV+ | 966 Participants | 139 Participants | 150 Participants | 177 Participants | 154 Participants | 175 Participants | 171 Participants |
| HIV Status HIV-/u | 1184 Participants | 193 Participants | 197 Participants | 198 Participants | 194 Participants | 201 Participants | 201 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2150 Participants | 332 Participants | 347 Participants | 375 Participants | 348 Participants | 376 Participants | 372 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 2150 participants | 332 participants | 347 participants | 375 participants | 348 participants | 376 participants | 372 participants |
| Sex: Female, Male Female | 2087 Participants | 314 Participants | 324 Participants | 375 Participants | 326 Participants | 376 Participants | 372 Participants |
| Sex: Female, Male Male | 63 Participants | 18 Participants | 23 Participants | 0 Participants | 22 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 177 | 0 / 154 | 3 / 198 | 0 / 194 | 3 / 171 | 0 / 150 | 0 / 201 | 0 / 197 | 1 / 175 | 0 / 139 | 0 / 201 | 0 / 193 |
| other Total, other adverse events | 0 / 177 | 0 / 154 | 0 / 198 | 0 / 194 | 0 / 171 | 0 / 150 | 0 / 201 | 0 / 197 | 0 / 175 | 0 / 139 | 0 / 201 | 0 / 193 |
| serious Total, serious adverse events | 0 / 177 | 0 / 154 | 0 / 198 | 0 / 194 | 0 / 171 | 0 / 150 | 0 / 201 | 0 / 197 | 0 / 175 | 0 / 139 | 0 / 201 | 0 / 193 |
Outcome results
Primary
HIV+ Proportion With Undetectable Viral Load at 12 Months
Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load
Time frame: At 12 months since study initiation
Population: Adolescent Girls and Young Women living with HIV in Lusaka, Zambia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV+ Proportion With Undetectable Viral Load at 12 Months | 99 Participants |
| SHIELD Only | HIV+ Proportion With Undetectable Viral Load at 12 Months | 74 Participants |
| SHIELD + IWC Clinic | HIV+ Proportion With Undetectable Viral Load at 12 Months | 76 Participants |
Primary
HIV Testing
Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.
Time frame: 6 months
Population: Adolescent Girls and Young Women not living with HIV in Lusaka, Zambia. The 6-month data collection was impacted by the COVID-19 pandemic and restrictions that were in place. We were unable to contact all of the participants we had enrolled at baseline as a result of pandemic restrictions which also caused participants to move away from their original enrollment catchment area. The reduction in participants should not be interpreted as drop-outs or those lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Testing | 33 Participants |
| SHIELD Only | HIV Testing | 52 Participants |
| SHIELD + IWC Clinic | HIV Testing | 139 Participants |
Primary
HIV-/u Proportion Tested for HIV in the Past 6 Months
Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months.
Time frame: 12 months
Population: Adolescent Girls and Young Women not living with HIV in Lusaka, Zambia. The 12-month data collection occurred after COVID-19 restrictions had been lifted. The participant count increases from the 6-month count because we were able to contact participants we had previously been unable to reach and participants had moved back to their original enrollment catchment area and could be included in the participant count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV-/u Proportion Tested for HIV in the Past 6 Months | 40 Participants |
| SHIELD Only | HIV-/u Proportion Tested for HIV in the Past 6 Months | 95 Participants |
| SHIELD + IWC Clinic | HIV-/u Proportion Tested for HIV in the Past 6 Months | 125 Participants |
Primary
Retention in Care
HIV+ cohort proportion with at least one visit during the 12-months follow-up. Data were not collected from any participant due to COVID 19 pandemic and associated restrictions, and will not be collected in the future.
Time frame: 12 months
Population: Data were not collected from any participant due to COVID 19 pandemic and associated restrictions, and will not be collected in the future.
Secondary
Adherence to ART
AGYW living with HIV who self-reported Excellent medication adherence.
Time frame: 12 months
Population: Zambian Adolescent and Young Women living with HIV. The 12-month data collection occurred after COVID-19 restrictions had been lifted. The participant count increases from the 6-month count because we were able to contact participants we had previously been unable to reach and participants had moved back to their original enrollment catchment area and could be included in the participant count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Adherence to ART | 71 Participants |
| SHIELD Only | Adherence to ART | 71 Participants |
| SHIELD + IWC Clinic | Adherence to ART | 84 Participants |
Secondary
Adherence to ART
AGYW living with HIV who self-reported Excellent medication adherence.
Time frame: 6 months
Population: Zambian Adolescent and Young Women living with HIV. The 6-month data collection was impacted by the COVID-19 pandemic and restrictions that were in place. We were unable to contact all of the participants we had enrolled at baseline as a result of pandemic restrictions which also caused participants to move away from their original enrollment catchment area. The reduction in participants should not be interpreted as drop-outs or those lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Adherence to ART | 69 Participants |
| SHIELD Only | Adherence to ART | 83 Participants |
| SHIELD + IWC Clinic | Adherence to ART | 93 Participants |
Secondary
HIV Early Detection
HIV-/u proportion with HIV identified through voluntary testing.
Time frame: 12 months
Population: Zambian Adolescent and Young Women not living with HIV. The 12-month data collection occurred after COVID-19 restrictions had been lifted. The participant count increases from the 6-month count because we were able to contact participants we had previously been unable to reach and participants had moved back to their original enrollment catchment area and could be included in the participant count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Early Detection | 2 Participants |
| SHIELD Only | HIV Early Detection | 2 Participants |
| SHIELD + IWC Clinic | HIV Early Detection | 1 Participants |
Secondary
HIV Risk Behavior - Delay in First Intercourse
Self reported age of first intercourse among HIV-/u cohort.
Time frame: 6 months
Population: Zambian Adolescent and Young women not living with HIV. The reason for seeing inconsistent participant sums for 6 month row is because a fewer number of participants were surveyed/tested because of COVID and individuals leaving the area.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Risk Behavior - Delay in First Intercourse | 17.10 years | Standard Deviation 1.73 |
| SHIELD Only | HIV Risk Behavior - Delay in First Intercourse | 16.95 years | Standard Deviation 1.76 |
| SHIELD + IWC Clinic | HIV Risk Behavior - Delay in First Intercourse | 16.94 years | Standard Deviation 1.66 |
Secondary
HIV Risk Behavior - Delay in First Intercourse
Self-reported age of first intercourse among HIV-/u cohort.
Time frame: Baseline
Population: Zambian Adolescent and Young Women not living with HIV. The reason why the Overall Number of Participants Analyzed is substantially smaller than other categories is because questions related to sexual behavior and activity can only be asked to individuals aged 15 and over in Zambia. Our HIV-/u cohort is the cohort that enrolled participants between the ages of 10 and 26 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Risk Behavior - Delay in First Intercourse | 16.48 years | Standard Deviation 2.36 |
| SHIELD Only | HIV Risk Behavior - Delay in First Intercourse | 16.85 years | Standard Deviation 1.7 |
| SHIELD + IWC Clinic | HIV Risk Behavior - Delay in First Intercourse | 16.88 years | Standard Deviation 1.63 |
Secondary
HIV Risk Behavior - Delay in First Intercourse
HIV-/u self reported age of first intercourse.
Time frame: 12 months
Population: Self-reported age of first intercourse among HIV-/u cohort. Reported values reflect results for those aged 16 and older since asking questions related to sexual behavior to those aged 15 and below in Zambia is illegal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Risk Behavior - Delay in First Intercourse | 17.22 years | Standard Deviation 1.7 |
| SHIELD Only | HIV Risk Behavior - Delay in First Intercourse | 17.20 years | Standard Deviation 2.04 |
| SHIELD + IWC Clinic | HIV Risk Behavior - Delay in First Intercourse | 17.28 years | Standard Deviation 1.45 |
Secondary
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: 6 months
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity can only be asked to individuals aged 15 and over in Zambia. Our HIV-/u cohort is the cohort that enrolled participants between the ages of 10 and 26 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Risk Behavior - Increases in Condom Use | 7 Participants |
| SHIELD Only | HIV Risk Behavior - Increases in Condom Use | 4 Participants |
| SHIELD + IWC Clinic | HIV Risk Behavior - Increases in Condom Use | 3 Participants |
Secondary
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: Baseline
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity can only be asked to individuals aged 15 and over in Zambia. Our HIV-/u cohort is the cohort that enrolled participants between the ages of 10 and 26 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Risk Behavior - Increases in Condom Use | 3 Participants |
| SHIELD Only | HIV Risk Behavior - Increases in Condom Use | 4 Participants |
| SHIELD + IWC Clinic | HIV Risk Behavior - Increases in Condom Use | 8 Participants |
Secondary
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: 12 months
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity can only be asked to individuals aged 15 and over in Zambia. Our HIV-/u cohort is the cohort that enrolled participants between the ages of 10 and 26 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Risk Behavior - Increases in Condom Use | 2 Participants |
| SHIELD Only | HIV Risk Behavior - Increases in Condom Use | 5 Participants |
| SHIELD + IWC Clinic | HIV Risk Behavior - Increases in Condom Use | 7 Participants |
Secondary
HIV Risk Behavior - Reduction in Sexual Partners
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Time frame: 12 months
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity cannot be asked to individuals aged 15 and under in Zambia. Our HIV-/u cohort enrolled participants between the ages of 10 and 24 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions. The number reported reflects the mean number of casual partners for all respondents who reported at least 1 sexual partner in each intervention group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | HIV Risk Behavior - Reduction in Sexual Partners | 1.09 Mean of Casual Partners |
| SHIELD Only | HIV Risk Behavior - Reduction in Sexual Partners | 1.15 Mean of Casual Partners |
| SHIELD + IWC Clinic | HIV Risk Behavior - Reduction in Sexual Partners | 1.14 Mean of Casual Partners |
Secondary
HIV Risk Behavior - Reduction in Sexual Partners
Self reported number of casual partners in the last 3 months among HIV-/u cohort.
Time frame: Baseline
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity cannot be asked to individuals aged 15 and under in Zambia. Our HIV-/u cohort enrolled participants between the ages of 10 and 24 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions. The number reported reflects the mean number of casual partners for all respondents who reported at least 1 sexual partner in each intervention group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | HIV Risk Behavior - Reduction in Sexual Partners | 1.14 Mean of Casual Partners |
| SHIELD Only | HIV Risk Behavior - Reduction in Sexual Partners | 1.10 Mean of Casual Partners |
| SHIELD + IWC Clinic | HIV Risk Behavior - Reduction in Sexual Partners | 1.06 Mean of Casual Partners |
Secondary
HIV Risk Behavior - Reduction in Sexual Partners
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Time frame: 6 months
Population: Zambian Adolescent and Young Women not living with HIV. Questions related to sexual behavior and activity cannot be asked to individuals aged 15 and under in Zambia. Our HIV-/u cohort enrolled participants between the ages of 10 and 24 and would, therefore, be most affected by the age restrictions in place for sexual behavior questions. The number reported reflects the mean number of casual partners for all respondents who reported at least 1 sexual partner in each intervention group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | HIV Risk Behavior - Reduction in Sexual Partners | 1.25 Mean of Casual Partners |
| SHIELD Only | HIV Risk Behavior - Reduction in Sexual Partners | 1.25 Mean of Casual Partners |
| SHIELD + IWC Clinic | HIV Risk Behavior - Reduction in Sexual Partners | 1.33 Mean of Casual Partners |
Secondary
Linkages to HIV Care - ART Initiation
Proportion with ART initiated in ≤ 90 days
Time frame: 6 months
Secondary
Linkages to HIV Care - ART Initiation
Proportion with ART initiated in ≤ 90 days
Time frame: 12 months
Secondary
Linkages to HIV Care - Enrollment at HIV Clinic
Proportion enrolled at an HIV clinic in ≤ 30 days
Time frame: 6 months
Secondary
Linkages to HIV Care - Enrollment at HIV Clinic
Proportion enrolled at an HIV clinic in ≤ 30 days
Time frame: 12 months