1. Can Self-collected Vaginal Swabs Facilitate Testing for Repeat Chlamydia trachomatis Infections among STD Clinic Clients
Good morning everyone! I am going to present a study about screening for repeat chlamydia infection.

2. Fujie Xu, David Martin, Bradley Stoner, Leandro Mena, Stephanie Taylor, John Papp, Kathleen Hutchins, Lauri Markowitz Centers for Disease Control, Atlanta, Georgia Louisiana State University, New Orleans, LA Washington University, St Louis, MO University of Mississippi Medical Center, Jackson, MS
This study was conducted in collaboration with investigators at Louisiana State University, Washing University and the University of Mississippi Medical Center.
I would like to thank Drs David Martin, Bradley Stoner, Leandro Mena, Stephanie Taylor and my colleagues at CDC.

3. Background
Repeat Chlamydia infections are common in women; repeat infection may be associated with increased risk for long-term sequelae
CDC guidelines recommend re-screening 3 months after initial treatment
The need for a clinic visit and a vaginal speculum examination are believed to contribute to poor compliance with re-screening recommendations
This study was conducted because, as you know, Repeat Chlamydia infections are common in women, and repeat infection may be associated with increased risk for long-term sequelae, such as PID or infertility.
CDC’s STD Treatment Guidelines recommend rescreening all women about 3 months after initial treatment. However, compliance with routine rescreening is generally low. The need for a clinic visit and pelvic exam may contribute to the poor compliance.

4. Objectives and Study Populations
To evaluate use of home-based, self-collected vaginal swabs to facilitate re-screening
Study populations: Women with a positive test for Chlamydia recruited from:
STD clinics
Family Planning clinics (preliminary)
The study objective is to see if we can increase rescreening by the use of home-based, self-collected vaginal swabs.
We recruited women who tested positive and treated for chlamydia from STD clinics and family planning clinics.
We conducted two parallel trials following the same protocol.
My presentation today will focus on data from the STD clinics.

5. Study design
Multi-site randomized controlled trial to compare the rate of re-screening between two groups:
Home Group
These women would receive a specimen collection kit by mail, collect a vaginal swab at home, and mail it back
Clinic Group
These women would be given a clinic appointment for testing
Two recruiting methods
In-person
By phone (patients who were empirically treated)
Re-screening scheduled at 3 m following prior treatment
Up to two reminder calls were made about 2 weeks before scheduled re-screening in both groups
The study design is multi-site randomized trial. Women were randomly assigned, by opening a pre-made randomization envelop, to either the Home Group or the Clinic Group.
Women assigned to the Home Group would receive a specimen collection kit by mail, collect a vaginal swab at home, and mail it back in a postage-paid mailer.
Women assigned to the Clinic Group would be given a clinic appointment for testing.
The study participants were recruited in person, or by phone.
The re-screening was scheduled at 3 months following prior treatment. And up to two reminder calls were made to both groups. The first reminder call was made about 2 weeks before scheduled re-screening date. If the participant did not mail back a self-collected vaginal swab or did not visit the clinic following the first call, we tried to make a 2nd reminder call about 2 weeks later.

6. Study hypotheses
The percent of women re-screened will be low in Clinic Group (25% or lower)
The percent of women re-screened will be higher in Home Group compared with Clinic Group
We made the assumption that the percent of women re-screened in the Clinic Group will be 25% or lower.
The percent of women re-screened will be higher in Home Group compared with Clinic Group

7. The mailer
This is the mailer we sent to women assigned to the Home Group. The picture on the right shows the triple packaging that met the United States Postal Service standards and the requirements for shipping diagnostic specimens

8. The instructions for self-collection
In the mailer, we provided women with instructions on how to collect, and how to package and mail the self-collected vaginal swabs.

9. Lab Methods
APTIMA-TMA (Gen-Probe®): the only FDA-cleared vaginal swab test
Home Group:
One self-collected vaginal swab mailed directly to the study lab in New Orleans
Clinic Group:
Two vaginal swabs (and endocervical swabs)
We used the Aptima-TMA test in our study. Women assigned to the Home Group sent the self-collected vaginal swab directly to the study lab in New Orleans.
Two vaginal swabs were collected from Women assigned to the Clinic Group. The clinics mailed one of the two swabs by US post service and the other by express delivery. In St Louis, an endocervical swabs was also collected for the purpose of providing standard clinical care.

10. Results
We enrolled 877 participants from October 2004 through August 2007
Due to Hurricane Katrina we excluded 69 participants
Our analyses included 808 participants
407 in the Home Group
401 in the Clinic Group
We enrolled a total of 877 participants. Enrollment started in October 2004 and ended in August 2007
Due to Hurricane Katrina we have to exclud 69 participants
Our analyses included 808 participants
407 in the Home Group
401 in the Clinic Group

11. Results Characteristics of the study population
As expected, women assigned to the Home Group and Clinic Group are similar regarding age and other demographic characteristics.
The mean age was around 22; about 85% of women had high school or higher education; 93% were African American; near 80% were currently working or in school and over 90% were single.

12. Results Percent of women re-screened
Characteristics
Home
Group
Clinic
P-value
Overall
31.9%
25.4%
0.04
Tested within 4 weeks* of scheduled re-screening
21.3%
15.5%
By study site*
Jackson (n=339)
New Orleans (n=268)
St Louis (n=201)
27.2%
13.2%
21.6%
22.9%
7.6%
13.1%
0.36
0.13
0.11
This is our first result slide.
Overall, 31.9% of women or girls assigned to the Home Group were tested for chlamydia, compared to 25.4% in the Clinic Group. The differences are statistically significant.
Per our study protocol, rescreening was defined as testing within the 4 week-window period around the date of the scheduled rescreening date, which was calculated as 90 days after prior treatment. The window period ranged from 1 week before to 3 weeks after the date of the scheduled re-rescreening date.
21.3% of those assigned to the Home Group were tested within the 4 weeks, compared to 15.5% in the Clinic Group.
The rescreening rates varied by study site, but the rates were consistently higher in the Home Group than in the Clinic Group.
*Tested per protocol (within 1 week before and 3 weeks after scheduled re-screening).

13. Results Percent of women re-screened* (continued)
Characteristics
Sample
Size
Home
Group
Clinic Group
P-value
Age
<22 years
>22 years
Education level
<Middle school
>High school
Working or in school
Yes No
452
355
119
685
624
181
21.4%
20.8%
15.6%
22.3%
22.8%
15.4%
17.7%
12.2%
20.0%
14.8%
17.5%
8.7%
0.32
0.03
0.53
0.01
0.10
0.15
This slide shows the rescreening rates by age, educational level and whether or not the participant was working or in school.
Please note that that in two groups: women who were 22 years of age or older and women who had high school or above education, the rescreening rates were significantly higher in the Home Group than in the Clinic Group.
*Tested per protocol (within 1 week before and 3 weeks after scheduled rescreening).

14. Results Percent of women tested by call status
By reminder call
Sample
Size
Home
Group
Clinic Group
P-value
Among those called
Reached
Not reached
Reached (withdrew from study)
No reminder call form
406
318
26*
52**
55.4%
2.0%
11.1%
11.5%
47.3%
4.7%
12.5%
7.7%
0.1
0.2
0.9
0.6
The reminder call made a huge difference: Among those who were called and reached, 55.4% in the Home Group and 47.3% in the Clinic Group were tested for chlamydia. Among the participants can not be reached by the call, the rates of testing were low in both groups.
When reached by phone, 26 women decided to withdraw from our study. For 52 participants, the reminder call form was missing or incomplete. At least some of these participants were not called.
*8 were assigned to the Home Group and 18 were from the Clinic Group.
** Equal numbers in Home and Clinic Group

15. Results Chlamydia test positivity rates*
Characteristics
Home
Group
Clinic
P-value
Overall
By site
Jackson
New Orleans
St Louis
14.6% (12/82)
13.3% (6/45)
11.8% (2/17)
20.0% (4/20)
17.2% (10/58)
19.4% (7/36)
30.0% (3/10)
0% (0/12)
0.68
0.46
0.24
0.10
Among women tested during the 4-week period, 14.6% in the Home Group tested positive. In the Clinic Group, the overall test positivity rate was 17.2%. The positivity rates were not different by group assignment.
*Tested within 1 week before through 3 weeks after the scheduled rescreening

16. Results Mailing time and cost for Home Group
Interval between reported swab collection date and the date the swab was received in the study lab:
Median (days)
Overall:
By site: Jackson 8
New Orleans 7
St Louis 9
It looks like most women mailed the swab shortly after collecting the specimen. The median interval between the date of specimen collection and the date the swab arrived in the study lab was 8 days.
Cost:

17. Family Planning Clinics (Preliminary data, N=404)
Demographics:
Mean age=21; 88% African American; 85% working or in school; 93% single
Rescreening rates:
48% in Home Group, and 28% in Clinic Group (P<0.001).
27% in Home Group and 20% in Clinic Group were tested within the 4w window (P=0.1)
Among those reached by reminder call, 71% in Home Group, and 53% in Clinic Group (P=0.005).
Test positivity:
14% in Home Group and 12% in Clinic Group (P= 0.8)
Now, let me briefly present some results from the parallel trial among Family Planning Clinic attendees.
Enrollment for this trial continued through December As you can see, the Family Planning population is somewhat different.
We looked at the rescreening rates in three ways and the percentages of women tested were all higher in the Home Group than the Clinic Group. Also, the Group-specific rates were higher in the Family Planning clinics than in the STD clinics.
Unfortunately, the bad new is that, among women enrolled from Family Planning Clinics, the test positivity rates were also high.

18. Conclusions and Discussion
Home-based, self-collected vaginal swabs clearly provide women an alternative to clinic-based re-screening for Chlamydia
Difference by study group was significant but not as great as expected
If possible, allow women to choose between options may help to increase overall compliance
Currently, the vaginal swab test is FDA cleared for use in clinical settings only; our data indicate a role for home-based specimen collection

19. Conclusions and Discussion (2)
A reminder call was the key to increase re-screening rates for both groups; without a reminder, the re-screening rates were low
A high proportion of participants could not be reached by phone; contact methods other than phone calls should be explored to remind patients about re-screening
The findings and conclusions in this presentation are those of the author(s) and do not necessarily represent the views of the CDC/ATSDR