# Presentation: 681960

## Once Is Not Enough: Re-screening Sexually Transmitted Disease (STD) Clinic Patients in Six Months to Detect New STDs 

- Bolu, Omotayo1; Lindsey, C1; Peterman, T1; Kamb, M1; Bolan, G2; Zenilman, J3; Douglas, J4; Malotte K5; Rogers J6, for the Project RESPECT study group
- 1Division HIV/AIDS Prevention, CDC, Atlanta, Georgia
- 2San Francisco Health Department
- 3Baltimore City Health Department & Johns Hopkins University
- 4Denver Public Health , Colorado Department of Health and Environ.
- 5 Long Beach Health Department and California State University
- 6 New Jersey Health Department (Trenton) & Newark STD Clinic
** **

## BackgroundandObjectives

**STD clinic patients** :
- 	-	Are at risk for new STDs
- 	-	Do not always return to the clinic when they
-            have a new infection since many STDs are
- 			- asymptomatic
- Should STD clinic patients return in 6 months for re-screening because they may have a new STD ?

**Notes:**
Studies have found that STD clinic patients are at risk for new STDs, however, many of these patients do not always return to the clinic when they have a new infection because many STDs are asymptomatic, unrecognized, and will therefore go untreated, thus contributing to its spread and resulting in complications such as pelvic inflammatory disease in women and epididymitis in men . Our question is: Should we ask STD clinic patients to return in 6 months for re-screening because they may have a new STD ? and if yes, which  STD clinic patients.

## Objectives

- Determine :
- 1.	 What percentage of STDs would be missed if STD clinic patients are not scheduled for follow-up visit
- 2.	 Which STD clinic patients should be scheduled for
-      follow-up visit

**Notes:**
The objectives of our study were : 
To determine what percentage of STDs would be missed if STD clinic patients are not scheduled for follow-up visit and, 
which STD clinic patients should be scheduled for follow-up visit

## Methods

## Project RESPECT

- Arm 1
- 1438

- Arm 2
- 1447

- Arm 4
- 1430

**Cities:****	**         	 Baltimore, Denver, Newark, Long Beach, San Francisco
**Participants:****	** Heterosexual STD clinic patients; > 14 years; HIV -

- Arm 3
- 1443

**5758 participants**

-           4328 had 6-month
-         scheduled appointment
-       (Days 161-219 after baseline)

- No scheduled visit

**All participants: ****	**Return anytime for STD exam
**New STDs:****	**     	Gonorrhea, Chlamydia, Syphilis, HIV

**Notes:**
We analyzed data form Project RESPECT, a randomized controlled trial conducted in 5 US cities:  Baltimore, Denver, Newark, Long Beach, and San Francisco.  Participants were heterosexual STD clinic patients, aged 14 years and above, were HIV negative and had had vaginal sex in the last 3 months. Participants were randomized into four arms with varying number of counseling sessions. 
Participants in arms 1,2, and 3 were paid some monetary incentives, and asked to return for a scheduled STD exam at 6 months and a questionnaire visit at 3 and 6 months. The 6-month scheduled appointment was defined as days 161-219 days after baseline because clients came in at varying times for their appointment. Participants were also informed to return anytime, they had or suspected STD symptoms. 	
Participants in arm 4 were not given a 6–month  scheduled visit appointment, but were asked to return anytime, they had or suspected STD symptoms. 
The outcomes of interest were new STDs: Gonorrhea, Chlamydia, Syphilis and HIV.The 6 month scheduled

## Participants divided into two groups:

- 	-	Scheduled follow-up: 	   Arms 1, 2, & 3	(N=4328)
- 	 -	No scheduled follow-up:	  Arm 4 	    	(N=1430)
- 	 -	 Arm 4 (N=1430) x 3.0265      			(N=4328)
-    		  (to adjust for group size)
- The number of new STDs diagnosed in both groups over the entire 6-month study period were counted

**Notes:**
In our analysis , we divided the participants into two main groups:
The scheduled follow-up group, comprising of arms 1,2, and 3 participants, who were scheduled for an appointment including STD examination at 6 months after the baseline visit. Their sample size was 4328
The no scheduled follow-up group, comprising of arm 4 participants and were not scheduled for an appointment at 6 months. Their sample size was 1430.
Remember that all participants could return anytime they had or suspected STD symptom. 
Because of the sample size difference between the scheduled group and the unscheduled group, we multiplied the unscheduled group or arm 4’s sample size by 3.0265 to adjust for group size at baseline. We counted the no.of new STDs diagnosed in both groups over the entire 6-month study period. 

## 
To estimate STDs that would have been missed if clients were not scheduled for 6-month (days 161-219 after baseline) follow-up visit:

	- 	   New STDs in            __           New STDs in 
   		Scheduled group 		       unscheduled group

Subgroup analysis: identified predictors for STDs that would have been missed if no scheduled follow-up visit

- To estimate STDs that would have been missed if clients were not scheduled for 6-month (days 161-219 after baseline) follow-up visit:
- 	- 	   New STDs in            __           New STDs in
-    		Scheduled group 		       unscheduled group
- Subgroup analysis: identified predictors for STDs that would have been missed if no scheduled follow-up visit

**Notes:**
To estimate STDs that would have been missed if clients were not scheduled for 6-month exam, we subtracted new STDs diagnosed during  the 6-month scheduled period (Days 161-219 days after baseline) in the no scheduled group from the scheduled group. We counted participants only once during the 6 month period i.e. the first time they came in during this scheduled period. We also conducted a subgroup analysis to identify predictors for STDs at 6 months, using the same calculations, that is subtracting new STDs in the unscheduled from the scheduled group during the 6-month scheduled period for each subgroup.

## Results

##  6 month 

- <footer>

- <date/time>

-  6 month
- period

**Notes:**
This graph shows the number of STDs that occurred in the two groups from the time they had baseline visit up to 220 days after baseline visit. The X-axis represents the days past baseline visit, while the Y axis represents the number of new STDs, the yellow bars are for the scheduled group and the purple bar for the unscheduled group. Before the 6 month scheduled period which is from day 1 after baseline visit to day 160, the number of new STDs for the two groups are somewhat similar. 

From days 161-219 days which is the 6 month scheduled period and, represented by the black arrow, the number of new STDs in the scheduled group was about six times the number of new STDs in the unscheduled group.

- During the 6 month scheduled period (Days 161-219):
- 238 new STDs : 56% chlamydia (CT); 31% gonorrhea
-    (GC); 8% CT & GC; 4% syphilis; 0.5% GC,CT & syphilis;
-    0.5% HIV
- Scheduled follow-up :      2709 (63%) returned
- 				           202 new STDs
- No scheduled follow-up :     36 new STDs
-                                           166 new STDs would have
- 					    been missed if no scheduled visit.
- 6% (166/2709) of those returning had new STDs

**Notes:**
During the 6-month scheduled period there were 238 new STDs overall the majority were chlamydia 60%,  followed by gonorrhea 27%. 2709 participants returned in the scheduled follow-up group, of these 202 had a new STD.  In the no scheduled follow-up group, 36 people had  a new STD during this period.  
This means that 166 new STDs could have been missed if clients were not asked to return for a scheduled visit. The 166 new STDs were obtained by subtracting 36 new STDs in the unscheduled group from 202 in the scheduled group Therefore 6% of those returning  may not have had their STD diagnosed if they had not been scheduled for a follow-up visit. 

## Predictors for Missed STDs

| Predictors | STD  incidence | RR (95%CI), P-value |
| --- | --- | --- |
| Baseline STD
   Yes
   No
Age (years)
   14-25 
   > 25  
Gender
   Female
   Male
City
   Newark 
   Baltimore
   Denver
   Long Beach
   San Francisco | 
11.9
  4.1

 7.8
 4.7

 6.2
 6.0

11.3
  6.4
  5.2
  4.2
  3.7 | 
     3.3(2.4–4.6),   <0.0001
               Ref

     1.7(1.2–2.2),   <0.001
              Ref

     0.9(0.8–1.3),     0.78
              Ref

     3.6(2.2–5.9),   <0.0001
     2.1(1.2–3.6),     0.008
     1.6(1.0–2.8),     0.06
     1.7(1.0–2.3),     0.05
               Ref |

**Predictors for Missed STDs**

**Notes:**
This slide shows the predictors for STDs that could have been missed if there was no scheduled 6 month visit. We only looked at predictors that are readily visible to the clinician, and can be used to make a quick assessment as to whether clients should return for a scheduled visit, rather than self reported predictors such as number of partners and use of condoms which may not be as reliable. 
The highest incidence of STDs were among persons with baseline STD (11.9%), followed by persons from Newark (11.3%), and persons aged 14-25 years old (7.8%).
The strongest predictors for having STDs that would have been missed if there was no scheduled visit were baseline STD (RR =3.3) compared with no baseline STD; being from Newark(RR=3.6) and  Baltimore(RR=2.1) compared with san Francisco; and age 14-25 (RR 1.7) compared with persons >25 years old.  There was no difference by gender

##    Percentages of new STDs at 6 months among persons with baseline STD by site 

-    **Percentages of new STDs at 6 months among persons with baseline STD by site **

|  Site |    All 
persons
% | Persons with baseline STD                              
% |
| --- | --- | --- |
| Newark 
Baltimore
Denver
Long Beach
San Francisco
 | 11.3
  6.4
  5.2
  4.2
  3.7 | 18.0
8.3
 5.9
10.5
11.3 |

**Notes:**
Because baseline STD and site were the strongest predictors we wanted to find out if low STD incidence in one site also meant low STD incidence among persons with baseline STD in those sites. By stratifying baseline STD by site, we found that SF which had low incidence of new STDs (3.7%) had the second largest incidence (11.3%), the same occurred for Long Beach.  So even in these sites with low overall incident STDs at follow-up, there is a high incidence among persons who had an STD at baseline. 

## Summary of Results

- Of those returning in the scheduled group, 6% had a new STD that would have been missed if there was no scheduled visit
- The main predictor is having a baseline STD: 12% had a new STD

**Notes:**
In summary, of those returning in the scheduled group, 6% had a new STD that could have been missed if they were not asked to return for a scheduled visit.  The main predictor of  STD at the 6 month scheduled visit was having a baseline STD, 12% of persons with baseline STD had a new STD which would have been missed if there was no scheduled follow-up. 

## 	Limitation	

- Diagnostic test for chlamydia in the unscheduled group was less sensitive and may have underestimated the number of new STDs in this group

**Notes:**
One limitation to this study is that the diagnostic test used for CT in both groups were different, they were less sensitive for participants in the unscheduled group and this may have underestimated the number of new STDs in the unscheduled group and this may have accounted for the slight difference in new STDs in both groups prior to the 6 month scheduled visit.

## Conclusions

- 6% of STD clinic patients had a new STD, which would have been missed if they were not scheduled for a visit.
- The main predictor : Baseline STD (12%)
**Recommendation**
- Persons with baseline STD should be asked to
- return for re-screening at six months because
- many would have a new STD

**Notes:**
To conclude, 6% of STD clinic patients had a new STD, which would have been missed if a scheduled visit for an STD exam was not recommended. The main  predictor for having an STD that could have been missed was having a baseline STD, 12% with baseline STD would have been missed if they were not asked to return. Our recommendation is that persons with baseline STD irrespective of city or gender should be asked to return for re-screening at six months because many may have a new infection.  Thank you. 

## Tests performed

| Organism | Tests performed |
| --- | --- |
| GC

CT

Syphilis

HIV | Culture for women and men or gram stain for men
PCR endocervical swab in women, Urine in men
Hx, P/E, + supportive treponemal and nontreponemal antibody test

Repeated EIA |

## Calculating Predictors

| Chara-
cteristics | Number returning | Scheduled | Unscheduled | Missed STDs 
(%) |
| --- | --- | --- | --- | --- |
| Baseline 
STD  | 692 | 100
 | 18 | 82/692
(11.9) |
| NO STD | 2017 | 102 | 18 | 84/2017
(4) |