Trial Outcomes & Findings for Intervention to Retain HIV-positive Patients in Medical Care (NCT NCT01537367)

Last Updated: 2013-09-09

Results Overview

Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.

Recruitment status

COMPLETED

Study phase

Target enrollment

1838 participants

Primary outcome timeframe

12 months after enrollment

Results posted on

2013-09-09

Participant Flow

Recruitment occurred from June 15, 2010 through February 11, 2011. Recruitment time varied from 6 months to 8 months, by clinic site. Recruitment always occurred during regularly scheduled primary care appointments, either in a private corner of the waiting room, or in an adjacent room of the clinic.

No exclusions from the trial if participant was deemed eligible and agreed to participate. Once participants were deemed eligible, and agreed, they were escorted to a private room to do the audio-CASI questionnaire. After the audio-CASI was completed they were immediately randomized to one of the three arms.

Participant milestones

Participant milestones
Measure	Enhanced Contact-only The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.	Enhanced Contact-plus Behavioral Skills This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.	Standard of Care Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
Overall Study STARTED	615	610	613
Overall Study COMPLETED	615	610	613
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention to Retain HIV-positive Patients in Medical Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Contact-only n=615 Participants The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.	Enhanced Contact-plus Behavioral Skills n=610 Participants This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.	Standard of Care n=613 Participants Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.	Total n=1838 Participants Total of all reporting groups
Age, Customized 18-29 years	59 participants n=5 Participants	67 participants n=7 Participants	73 participants n=5 Participants	199 participants n=4 Participants
Age, Customized 30-39 years	118 participants n=5 Participants	121 participants n=7 Participants	122 participants n=5 Participants	361 participants n=4 Participants
Age, Customized 40-49 years	210 participants n=5 Participants	202 participants n=7 Participants	212 participants n=5 Participants	624 participants n=4 Participants
Age, Customized 50-59 years	187 participants n=5 Participants	176 participants n=7 Participants	167 participants n=5 Participants	530 participants n=4 Participants
Age, Customized 60-plus years	41 participants n=5 Participants	44 participants n=7 Participants	39 participants n=5 Participants	124 participants n=4 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	234 Participants n=7 Participants	228 Participants n=5 Participants	665 Participants n=4 Participants
Sex: Female, Male Male	412 Participants n=5 Participants	376 Participants n=7 Participants	385 Participants n=5 Participants	1173 Participants n=4 Participants
Race/Ethnicity, Customized Black	431 participants n=5 Participants	422 participants n=7 Participants	409 participants n=5 Participants	1262 participants n=4 Participants
Race/Ethnicity, Customized White	87 participants n=5 Participants	72 participants n=7 Participants	76 participants n=5 Participants	235 participants n=4 Participants
Race/Ethnicity, Customized Other race	18 participants n=5 Participants	15 participants n=7 Participants	20 participants n=5 Participants	53 participants n=4 Participants
Race/Ethnicity, Customized Hispanic	79 participants n=5 Participants	101 participants n=7 Participants	108 participants n=5 Participants	288 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months after enrollment

Population: Intention to Treat (ITT)

Outcome measures

Outcome measures
Measure	Enhanced Contact-only n=615 Participants The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.	Enhanced Contact-plus Behavioral Skills n=610 Participants This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.	Standard of Care n=613 Participants Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)	55.8 percent in care each 4 month period	55.6 percent in care each 4 month period	45.7 percent in care each 4 month period

PRIMARY outcome

Timeframe: 12 months after enrollment

Population: Intention to Treat (ITT)

Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.

Outcome measures

Outcome measures
Measure	Enhanced Contact-only n=615 Participants The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.	Enhanced Contact-plus Behavioral Skills n=610 Participants This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.	Standard of Care n=613 Participants Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).	72.5 Percentage of Pt kept visits/#scheduled	70.9 Percentage of Pt kept visits/#scheduled	67.2 Percentage of Pt kept visits/#scheduled

SECONDARY outcome

Timeframe: 12 months after enrollment

The rate of kept clinic visits per person over 12 months.

Outcome measures

Outcome measures
Measure	Enhanced Contact-only n=615 Participants The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.	Enhanced Contact-plus Behavioral Skills n=610 Participants This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.	Standard of Care n=613 Participants Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
Mean Counts Per Person (Rates) of Kept Visits.	4.12 # kept visits/person/12 months Standard Error 0.118	4.15 # kept visits/person/12 months Standard Error 0.115	3.59 # kept visits/person/12 months Standard Error 0.096

Adverse Events

Enhanced Contact-only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Contact-plus Behavioral Skills

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lytt I. Gardner, Ph.D., CDC Project Officer

Division of HIV/AIDS (Epidemiology Branch), National Center for HIV/Hepatitis/STD/Tuberculosis Prevention, Centers for Disease Control and Prevention

Phone: (404) 639-6163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place