Trial Outcomes & Findings for Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia (NCT NCT03995953)

Results Overview

Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2150 participants

Primary outcome timeframe

6 months

Results posted on

2025-09-15

Participant Flow

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.

Assigned to HIV+ or HIV-/u depending on their HIV status at the time of enrollment.

Participant milestones

Participant milestones
Measure	Control HIV+ AGYW HIV+ AGYW allocated to the control arm	Control HIV+ Caregiver Caregivers selected by HIV+ AGYW in the control arm.	Control HIV- AGYW HIV- AGYW allocated to the control arm	Control HIV- Caregivers Caregivers selected by HIV- AGYW in the control arm.	SHIELD HIV+ AGYW HIV+ AGYW allocated to the SHIELD only arm.	SHIELD HIV+ Caregivers Caregivers selected by HIV+ AGYW in the SHILED only arm.	SHEILD HIV- AGYW HIV- AGYW allocated to the SHIELD only arm	SHIELD HIV- Caregivers Caregivers selected by HIV- AGYW allocated to the SHIELD only arm.	SHIELD+IWC HIV+ AGYW HIV+ AGYW allocated to the SHIELD + IWC arm	SHIELD+IWC HIV+ Caregivers Caregiver selected by HIV+ AGYW in the SHIELD+IWC arm.	SHIELD+IWC HIV- AGYW HIV- AGYW allocated to the SHIELD+IWC arm.	SHIELD+IWC HIV- Caregivers Caregivers selected by HIV- AGYW in the SHIELD+IWC arm.
Overall Study STARTED	177	154	198	194	171	150	201	197	175	139	201	193
Overall Study 6 Months	137	88	177	125	139	92	181	149	148	83	179	136
Overall Study 12 Months	153	100	175	162	147	106	184	166	145	103	178	152
Overall Study COMPLETED	153	100	175	162	147	106	184	166	145	103	178	152
Overall Study NOT COMPLETED	24	54	23	32	24	44	17	31	30	36	23	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Control HIV+ AGYW HIV+ AGYW allocated to the control arm	Control HIV+ Caregiver Caregivers selected by HIV+ AGYW in the control arm.	Control HIV- AGYW HIV- AGYW allocated to the control arm	Control HIV- Caregivers Caregivers selected by HIV- AGYW in the control arm.	SHIELD HIV+ AGYW HIV+ AGYW allocated to the SHIELD only arm.	SHIELD HIV+ Caregivers Caregivers selected by HIV+ AGYW in the SHILED only arm.	SHEILD HIV- AGYW HIV- AGYW allocated to the SHIELD only arm	SHIELD HIV- Caregivers Caregivers selected by HIV- AGYW allocated to the SHIELD only arm.	SHIELD+IWC HIV+ AGYW HIV+ AGYW allocated to the SHIELD + IWC arm	SHIELD+IWC HIV+ Caregivers Caregiver selected by HIV+ AGYW in the SHIELD+IWC arm.	SHIELD+IWC HIV- AGYW HIV- AGYW allocated to the SHIELD+IWC arm.	SHIELD+IWC HIV- Caregivers Caregivers selected by HIV- AGYW in the SHIELD+IWC arm.
Overall Study Death	3	0	3	0	3	0	0	0	1	0	0	0
Overall Study Lost to Follow-up	6	54	3	32	5	44	0	31	8	36	5	41
Overall Study Withdrawal by Subject	4	0	1	0	1	0	1	0	3	0	3	0
Overall Study Health Issues	0	0	0	0	1	0	0	0	4	0	0	0
Overall Study Relocated	11	0	16	0	14	0	16	0	14	0	15	0

Baseline Characteristics

Total number of participants to be divided out by HIV status

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGYW Control n=375 Participants One-time Education (AGYW)	AGYW SHIELD Only n=372 Participants SHIELD Intervention (AGYW)	AGYW SHIELD + IWC Clinic n=376 Participants SHIELD Intervention and Integrated Wellness Clinic (AGYW)	Caregiver Control n=348 Participants Caregivers appointed by those in AGYW Control.	Caregiver SHIELD Only n=347 Participants Caregivers appointed by those in AGYW SHIELD Intervention.	Caregiver SHIELD + IWC Clinic n=332 Participants Caregivers appointed by those in AGYW SHIELD Intervention and Integrated Wellness Clinic.	Total n=2150 Participants Total of all reporting groups
Age, Categorical <=18 years	219 Participants n=375 Participants	197 Participants n=372 Participants	194 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	610 Participants n=2150 Participants
Age, Categorical Between 18 and 65 years	156 Participants n=375 Participants	175 Participants n=372 Participants	182 Participants n=376 Participants	341 Participants n=348 Participants	340 Participants n=347 Participants	324 Participants n=332 Participants	1518 Participants n=2150 Participants
Age, Categorical >=65 years	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	7 Participants n=348 Participants	7 Participants n=347 Participants	8 Participants n=332 Participants	22 Participants n=2150 Participants
Age, Continuous	17.9 years STANDARD_DEVIATION 3.8 • n=375 Participants	18.1 years STANDARD_DEVIATION 3.8 • n=372 Participants	18.0 years STANDARD_DEVIATION 3.8 • n=376 Participants	37.3 years STANDARD_DEVIATION 11.3 • n=348 Participants	37.7 years STANDARD_DEVIATION 11.8 • n=347 Participants	36.6 years STANDARD_DEVIATION 11.9 • n=332 Participants	27.2 years STANDARD_DEVIATION 12.8 • n=2150 Participants
Age, Customized HIV+	20.8 years STANDARD_DEVIATION 2.5 • n=177 Participants • Total number of participants to be divided out by HIV status	21.0 years STANDARD_DEVIATION 2.5 • n=171 Participants • Total number of participants to be divided out by HIV status	21.0 years STANDARD_DEVIATION 2.3 • n=175 Participants • Total number of participants to be divided out by HIV status	39.8 years STANDARD_DEVIATION 11.7 • n=154 Participants • Total number of participants to be divided out by HIV status	39.2 years STANDARD_DEVIATION 11.7 • n=150 Participants • Total number of participants to be divided out by HIV status	38.5 years STANDARD_DEVIATION 12.2 • n=139 Participants • Total number of participants to be divided out by HIV status	29.3 years STANDARD_DEVIATION 12.3 • n=966 Participants • Total number of participants to be divided out by HIV status
Age, Customized HIV-/U	15.3 years STANDARD_DEVIATION 2.7 • n=198 Participants • Total number of participants to be divided out by HIV status	15.6 years STANDARD_DEVIATION 2.9 • n=201 Participants • Total number of participants to be divided out by HIV status	15.5 years STANDARD_DEVIATION 2.9 • n=201 Participants • Total number of participants to be divided out by HIV status	35.4 years STANDARD_DEVIATION 10.7 • n=194 Participants • Total number of participants to be divided out by HIV status	36.6 years STANDARD_DEVIATION 11.7 • n=197 Participants • Total number of participants to be divided out by HIV status	35.3 years STANDARD_DEVIATION 11.4 • n=193 Participants • Total number of participants to be divided out by HIV status	25.5 years STANDARD_DEVIATION 13.0 • n=1184 Participants • Total number of participants to be divided out by HIV status
Sex: Female, Male Female	375 Participants n=375 Participants	372 Participants n=372 Participants	376 Participants n=376 Participants	326 Participants n=348 Participants	324 Participants n=347 Participants	314 Participants n=332 Participants	2087 Participants n=2150 Participants
Sex: Female, Male Male	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	22 Participants n=348 Participants	23 Participants n=347 Participants	18 Participants n=332 Participants	63 Participants n=2150 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	375 Participants n=375 Participants	372 Participants n=372 Participants	376 Participants n=376 Participants	348 Participants n=348 Participants	347 Participants n=347 Participants	332 Participants n=332 Participants	2150 Participants n=2150 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) Asian	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) Black or African American	375 Participants n=375 Participants	372 Participants n=372 Participants	376 Participants n=376 Participants	348 Participants n=348 Participants	347 Participants n=347 Participants	332 Participants n=332 Participants	2150 Participants n=2150 Participants
Race (NIH/OMB) White	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) More than one race	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=375 Participants	0 Participants n=372 Participants	0 Participants n=376 Participants	0 Participants n=348 Participants	0 Participants n=347 Participants	0 Participants n=332 Participants	0 Participants n=2150 Participants
Region of Enrollment Zambia	375 participants n=375 Participants	372 participants n=372 Participants	376 participants n=376 Participants	348 participants n=348 Participants	347 participants n=347 Participants	332 participants n=332 Participants	2150 participants n=2150 Participants
HIV Status HIV+	177 Participants n=375 Participants	171 Participants n=372 Participants	175 Participants n=376 Participants	154 Participants n=348 Participants	150 Participants n=347 Participants	139 Participants n=332 Participants	966 Participants n=2150 Participants
HIV Status HIV-/u	198 Participants n=375 Participants	201 Participants n=372 Participants	201 Participants n=376 Participants	194 Participants n=348 Participants	197 Participants n=347 Participants	193 Participants n=332 Participants	1184 Participants n=2150 Participants

PRIMARY outcome

Timeframe: 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.

Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.

Outcome measures

Outcome measures
Measure	Control n=177 Participants Control Group	SHIELD Only n=181 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=179 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Testing	33 Participants	52 Participants	139 Participants

PRIMARY outcome

Timeframe: 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.

Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months.

Outcome measures

Outcome measures
Measure	Control n=175 Participants Control Group	SHIELD Only n=184 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=178 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV-/u Proportion Tested for HIV in the Past 6 Months	40 Participants	95 Participants	125 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 12 months since study initiation

Population: Adolescent Girls and Young Women living with HIV in Lusaka, Zambia.

Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load

Outcome measures

Outcome measures
Measure	Control n=151 Participants Control Group	SHIELD Only n=143 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=141 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV+ Proportion With Undetectable Viral Load at 12 Months	99 Participants	74 Participants	76 Participants

SECONDARY outcome

Timeframe: 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.

Self-reported age of first intercourse among HIV-/u cohort.

Outcome measures

Outcome measures
Measure	Control n=40 Participants Control Group	SHIELD Only n=48 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=51 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Delay in First Intercourse	16.48 years Standard Deviation 2.36	16.85 years Standard Deviation 1.70	16.88 years Standard Deviation 1.63

SECONDARY outcome

Timeframe: 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.

Self reported age of first intercourse among HIV-/u cohort.

Outcome measures

Outcome measures
Measure	Control n=49 Participants Control Group	SHIELD Only n=56 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=56 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Delay in First Intercourse	17.10 years Standard Deviation 1.73	16.95 years Standard Deviation 1.76	16.94 years Standard Deviation 1.66

SECONDARY outcome

Timeframe: 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.

HIV-/u self reported age of first intercourse.

Outcome measures

Outcome measures
Measure	Control n=56 Participants Control Group	SHIELD Only n=68 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=61 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Delay in First Intercourse	17.22 years Standard Deviation 1.70	17.20 years Standard Deviation 2.04	17.28 years Standard Deviation 1.45

SECONDARY outcome

Timeframe: 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.

Self reported number of casual partners in the last 3 months among HIV-/u cohort.

Outcome measures

Outcome measures
Measure	Control n=39 Participants Control Group	SHIELD Only n=48 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=50 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Reduction in Sexual Partners	1.14 Mean of Casual Partners Interval 0.0 to 4.0	1.10 Mean of Casual Partners Interval 0.0 to 4.0	1.06 Mean of Casual Partners Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Self-reported number of casual partners in last 3 months among HIV-/u cohort.

Outcome measures

Outcome measures
Measure	Control n=49 Participants Control Group	SHIELD Only n=55 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=57 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Reduction in Sexual Partners	1.25 Mean of Casual Partners Interval 0.0 to 4.0	1.25 Mean of Casual Partners Interval 0.0 to 4.0	1.33 Mean of Casual Partners Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Self-reported number of casual partners in last 3 months among HIV-/u cohort.

Outcome measures

Outcome measures
Measure	Control n=59 Participants Control Group	SHIELD Only n=72 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=65 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Reduction in Sexual Partners	1.09 Mean of Casual Partners Interval 0.0 to 4.0	1.15 Mean of Casual Partners Interval 0.0 to 4.0	1.14 Mean of Casual Partners Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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.

HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

Outcome measures

Outcome measures
Measure	Control n=14 Participants Control Group	SHIELD Only n=21 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=16 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Increases in Condom Use	3 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

Outcome measures

Outcome measures
Measure	Control n=8 Participants Control Group	SHIELD Only n=8 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=6 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Increases in Condom Use	7 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

Outcome measures

Outcome measures
Measure	Control n=11 Participants Control Group	SHIELD Only n=13 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=14 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Risk Behavior - Increases in Condom Use	2 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

HIV-/u proportion with HIV identified through voluntary testing.

Outcome measures

Outcome measures
Measure	Control n=153 Participants Control Group	SHIELD Only n=147 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=145 Participants SHIELD Sessions and Integrated Wellness Clinic
HIV Early Detection	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Proportion enrolled at an HIV clinic in ≤ 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Proportion enrolled at an HIV clinic in ≤ 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Proportion with ART initiated in ≤ 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Proportion with ART initiated in ≤ 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

AGYW living with HIV who self-reported "Excellent" medication adherence.

Outcome measures

Outcome measures
Measure	Control n=137 Participants Control Group	SHIELD Only n=138 Participants SHIELD Education Sessions	SHIELD + IWC Clinic n=148 Participants SHIELD Sessions and Integrated Wellness Clinic
Adherence to ART	69 Participants	83 Participants	93 Participants

SECONDARY outcome

Timeframe: 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.

AGYW living with HIV who self-reported "Excellent" medication adherence.